PARKINSON DISEASE (Disorder)GRA-MYR-NDNCT07360977

Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)

A study testing bioactivated GRA for adult patients and bioactivated GRA for pediatric patients in people with PARKINSON DISEASE (Disorder) and Multiple Sclerosis (MS) - Relapsing-remitting, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 year to 75 years
Conditions the study is for: PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting, Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases
What is being tested?: bioactivated GRA for adult patients and bioactivated GRA for pediatric patients
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteItaly
Study dates: 29 Jan 2026to Feb 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female patients aged between 45-75 years old.
Clinical diagnosis of PD according to UK Brain Bank Criteria.
3 months of clinical stability before study enrolment.
Anti-parkinsonian medication is fixed for at least 3 months prior to study entry.
Male or female patients 18 years old or older.
Diagnosis of RR-MS according to McDonald criteria.

Show all 16Show fewer

Expanded Disability Status Scale(EDSS) lower or equal to 5.5.
Stable disease for at least 30 days prior to study entry.
Stable disease-modifying therapy for at least 3 months prior to study entry.
Common inclusion criteria for MS and PD:
No changes in drug treatment during 6 months-study treatment.
Patients understand and comply with the study procedure and are able to complete tests and examinations required by the project.
Written informed consent.
Eligible patients are those clinically stable;
Age range from 1 to 10, between 5 and 30 kg.
Patients not involved in other clinical trials.

Who cannot join

Absolute contraindications to Magnetic Resonance Imaging (MRI).
Concomitant neurological disease or severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia, or other central nervous system diseases such as stroke, epilepsy or psychiatric disorders;
Total score of Mini-Mental State Examination (MMSE)<24.
Participating in other clinical trials.
Pregnant/lactating.

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98124

Other trials in Italy

About this study

Official title: A Composition Comprising Glucoraphanin, Myrosinase and a Buffered Solution for Use in the Treatment of Neurodegenerative Diseases

Glucosinolates (GLs) are phytocompounds mainly found in the Cruciferae (Brassicacea) and Moringa oleifera plants. The hydrolysis of GLs by myrosinase led to the production of isothiocyanate (ITCs). ITCs consumption was associated with different health promoting effects, including to neuroprotective, anti-oxidant and anti-inflammatory capacities. In particular, they showed neuroprotective effects in experimental models of neurodegenerative diseases, including multiple sclerosis (MS) and Parkinson's disease (PD). From different GLs, different ITCs are originated. In particular, from glucoraphanin (GRA) the ITC sulforaphane (SFN) is obtained. The PI of the project is one of the proprietor of a patent (EP2908850B1) for the application of (Rs)-GRA with myrosinase in a buffered solution for the treatment of neurodegenerative diseases. The aim of this project is to evaluate the effects of the administration of bioactivated GRA in different cohorts of adult patients, affected by MS and PD, but also a cohort of pediatric patients affected by neuromuscolar and degenerative diseases. The effects of bioactivated (Rs)-GRA administration will be evaluated with a combination of clinical evaluations and a multiomic (metabolomic, genomic) approach.

Conditions: PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting, Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases
Being tested: bioactivated GRA for adult patients, bioactivated GRA for pediatric patients
Keywords: phytocompounds, Glucosinolates, isothiocyanate, Parkinson's disease, multiple sclerosis
Medical subject headings: Parkinson Disease, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bioactivated GRA for adult patientsDrug
adult dose: 50 mg/day of bioactivated GRA for 6 months
bioactivated GRA for pediatric patientsDrug
pediatric dose: 10 mg/day of bioactivated GRA for 6 months

Study groups in NCT07360977
Study group	Role	What they receive
PD patients receiving only standard therapy	No intervention	Patients affected by Parkinson's disease receiving only standard therapy
PD patients receiving bioactivated GRA	Experimental	Patients affected by Parkinson's disease receiving bioactivated GRA Receives: Drug: bioactivated GRA for adult patients
MS patients receiving only standard therapy	No intervention	Patients affected by multiple sclerosis receiving only standard therapy
MS patients receiving bioactivated GRA	Experimental	Patients affected by multiple sclerosis receiving bioactivated GRA Receives: Drug: bioactivated GRA for adult patients
Pediatric patients receiving only standard therapy	No intervention	Pediatric patients receiving only standard therapy
Pediatric patients receiving bioactivated GRA	Experimental	Pediatric patients receiving bioactivated GRA Receives: Drug: bioactivated GRA for pediatric patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
The score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. The scale is divided into four parameters: 0 (normal), 1 (mild), 2 (mild), 3 (moderate), and 4 (severe).
Measured: Baseline, 6 months (end of treatment), 12 months
Hoehn and Yahr scale
Parkinson's Disease Progression Stage Scale (Stage 1 to 5). The scale is a subset of the Unified Parkinson's Disease Rating Scale, which allows for a more nuanced assessment of daily activities and non-motor symptoms in the context of disease therapy.
Measured: Baseline, 6 months (end of treatment), 12 months
Expanded Disability Status Scale (EDSS) for Multiple Sclerosis patients
Evaluation of the degree of neurological disability in Multiple Sclerosis. The range of the EDSS Step includes 20 half steps from 0 to 10, with EDSS Step 0 corresponding to a completely normal examination and EDSS Step 10 to death due to MS
Measured: Baseline, 6 months (end of treatment), 12 months
Cognitive and Neuropsychological Assessments: Montreal Cognitive Assessment (MoCA) and Mini-mental state examination
The MoCA is a one-page 30-point test administered in approximately 10 minutes to dectect cognitive impairment. Scores range between 0 and 30, a score of 26 or over is considered to be normal.
The mini-mental state examination (MMSE) or Folstein test is a 30-point test to identify cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age
Measured: Baseline, 6 months (end of treatment), 12 months
Brief Repeatable Battery (BRB) of Neuropsychological Tests for Multiple Sclerosis patients
THE BRB consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory). Higher values represent a better outcome.
Measured: Baseline, 6 months (end of treatment), 12 months
Normalized Brain Volume (NBV)
Evaluation of global brain atrophy through the measurement of total brain volume normalized for head size using high-field Magnetic Resonance Imaging (MRI). Higher values indicate better brain volume preservation, while a decrease over time indicates progression of brain atrophy.
Measured: Baseline, 6 months (end of treatment), 12 months
Normalized Cortical Volume (NCV)
Evaluation of regional atrophy focusing on the cerebral cortex. Measurement of cortical gray matter volume normalized for head size using high-field MRI. This parameter is used to quantify the loss of cortical tissue specifically.
Measured: Baseline, 6 months (end of treatment), 12 months
Change from Baseline in Whole-Brain Fractional Anisotropy (FA) in Multiple Sclerosis Patients
FA is a DTI-derived metric that reflects the microstructural integrity of white matter. In Multiple Sclerosis, a reduction in FA values is a marker of axonal damage and demyelination, even in Normal Appearing White Matter (NAWM).The unit of measurement is the Ratio (Scale from 0 to 1, where 1 indicates maximum diffusion/directional integrity.
Measured: Baseline, 6 months (end of treatment), 12 months
Change from Baseline in Whole-Brain Mean Diffusivity (MD) in Multiple Sclerosis patients
MD measures the average magnitude of water diffusion. An increase in MD values in MS patients indicates loss of structural barriers, typically due to neurodegeneration, inflammation, or loss of myelin. This parameter provides a global index of tissue destruction.
Measured: Baseline, 6 months (end of treatment), 12 months
Non-Motor Symptoms Scale (NMSS) for Parkinson patients
It assesses 30 non motor symptoms across 9 domains, with scores ranging from 0 (no symptoms) to 12 per group (severity x frequency), resulting in a total score of 0 to 360, indicating the extent of the non-motor symptom burden. Lower score indicate fewer symptoms; a negative change from baseline indicates improvement in symptoms. Mean scores vary with disease severity, reflecting increased problems with sleep disturbances, mood, cognition, gastrointestinal function, etc.
Measured: Baseline, 6 months (end of treatment), 12 months
Quality of Life Assessment: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale.
Depression severity is assessed using the 17-item Hamilton Rating Scale for Depression (HRSD). Based on the total score, participants will be classified into the following levels: no depression (0-7), mild depression (8-13), moderate depression (14-18), severe depression (19-22), and very severe depression (≥23). The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire to evaluate the anxiety. The Hamilton Anxiety Rating Scale (HAM-A), which consists of 14 items, each rated on a 5-point scale. The total score, obtained by adding the individual items, ranges from 0 to 56. A score ≤17 indicates mild anxiety; 18-24 indicates mild to moderate anxiety; 25-30 indicates moderate to severe anxiety.
Measured: Baseline, 6 months (end of treatment), 12 months
Parkinson's Disease Quality of Life Questionnaire (PDQ-8)
It is a patient-reported outcome measure consisting of 8 items that assesses health-related quality of life in Parkinson's disease. It includes one representative item for each domain of the original PDQ-39: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort. Participants rate their experiences in the previous month using a 5-point Likert scale (0 = never to 4 = always). The total score is converted into a Summary Index (SI) ranging from 0 to 100, with higher scores indicating poorer health-related quality of life.Summary Index scores were interpreted as follows: 0-20 indicating good quality of life with minimal disease impact, 21-40 mild impairment, 41-60 moderate impairment, 61-80 marked impairment, and 81-100 severe impairment of quality of life.
Measured: Baseline, 6 months (end of treatment), 12 months
Parkinson's Disease Sleep Scale (PDSS-2)
The PDSS-2 is a 15-item self-administered questionnaire used to evaluate sleep disturbances and nocturnal symptoms in patients with Parkinson's Disease. It covers various domains including motor symptoms at night, sleep quality, and daytime sleepiness. Each item is scored on a 5-point Likert scale from 0 (never) to 4 (very often). The total score ranges from 0 to 60. A total score ≥ 15-18 is often considered indicative of clinically significant sleep disturbance.
Measured: Baseline, 6 months (end of treatment), 12 months
Change from Baseline in EuroQol-5D-3L Index Score
The EQ-5D-3L is a standardized instrument for measuring health-related quality of life. It consists of a questionnaire with 5 item: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. These responses are converted into a single index score (utility value) using a country-specific value set.
Measured: Baseline, 6 months (end of treatment), 12 months
Clinical Global Impression of Improvement (CGI-I)
The CGI-I is a clinician-rated scale that assesses how much the patient's illness has improved or worsened relative to a baseline state.It is scored on a 7-point Likert scale: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment
Measured: Baseline, 6 months (end of treatment), 12 months
Patient Global Impression of Change (PGI-C)
The PGI-C is a self-reported scale reflecting the patient's belief about the efficacy of treatment and their overall change in health status since the start of the study. It uses a 7-point scale where: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
Measured: Baseline, 6 months (end of treatment), 12 months

Secondary outcomes (7)

Changes in growth parameters, anthropometric measurements and pubertal status.
Evaluation of physical development and nutritional status. The following parameters will be measured: body weight (kg), height (cm), Body Mass Index (BMI, calculated as weight in kilograms divided by height in meters squared), and their respective percentiles adjusted for age, sex, and specific pathology. These measurements aim to assess the impact of the administration of the study composition on growth and development in the pediatric population. Additionally, pubertal development will be assessed using the Tanner Stage (Sexual Maturity Rating), which evaluates the progression of secondary sexual characteristics (breast development in girls, genital development in boys, and pubic hair in both) on a scale from 1 (pre-pubertal) to 5 (adult). This combined assessment aims to monitor the global growth trajectory and hormonal-physical maturation during the treatment.
Measured: Baseline, 3 , 6 (end of the treatment) , and 12 months
Changes in Electroencephalogram (EEG) Mean Frequency and Brain Electrical Activity.
Evaluation of cerebral electrical activity using the Micromed Brain Quick System (System Plus Evolution software) with a 48-channel recording head. Recordings will follow the International 10-20 system (or reduced electrode sets for infants < 40 cm). The signal will be processed with a sampling frequency of 256 Hz, a high-pass filter of 1.6 Hz, a low-pass filter of 30 Hz, and a sensitivity of 100 μV/cm. Assessments will include wakefulness, sleep deprivation, and afternoon rest. For patients with severe neurological conditions, video-EEG and polygraphy will be associated. The analysis focuses on background activity evolution and paroxysmal abnormalities according to ILAE guidelines.Unit of Measure: Qualitative and Quantitative neurophysiological parameters (presence/absence of epileptiform activity and mean frequency in Hz.
Measured: Baseline, 3, 6 ( end of the treatment), 12 months
Assessment of Swallowing Function via Dysphagia Outcome and Severity Scale (DOSS) in pediatric patients.
Evaluation of the severity of dysphagia (swallowing impairment). The DOSS is a 7-point scale used to systematically rate functional longitudinal changes in swallowing. Scores range from 1 (Severe dysphagia: nothing by mouth) to 7 (Normal in all situations).
Measured: baseline and 3, 6, 12 months
Changes in Psychomotor Development via Griffiths Mental Development Scales 3 (GMDS-3)
The Griffiths-3 Scale (Griffiths III) is a comprehensive developmental assessment for young children (birth to nearly 6 years) that measures mental and physical growth across five key domains: Foundations of Learning, Language \& Communication, Eye \& Hand Coordination, Personal-Social-Emotional, and Gross Motor.Unit of Measure: Developmental Quotient (DQ) score (Standardized score where the mean is 100 and the standard deviation is 15. Higher scores indicate more advanced development).
Measured: baseline and 3, 6, 12 months.
Pediatric Esophageal Motility and Dysphagia Assessment via High-Resolution Manometry (HRM).
Evaluation of oro-pharyngeal and esophageal motility using the HRM ManoScan™ ESO System. The procedure uses a catheter (max diameter 2.75 mm to 4.2 mm, selected based on age/weight) and follows international standards (e.g., German Guidelines for neurogenic dysphagia). Key metrics include the characterization of esophageal function and the study of the esophagogastric junction motility.Unit of Measure: Composite Score and Manometric Parameters (including mmHg for pressures and Chicago Classification v4.0 metrics).
Measured: baseline and 3, 6 ( end of the treatment), 12 months
Metabolomics and Pharmacokinetic Analysis of Bioactive Compounds and Endogenous Metabolites in pediatric, PD and MS patients
Evaluation of the metabolic profile in human biofluids (plasma and urine) using Liquid Chromatography-Mass Spectrometry (LC-MS). The analysis includes:
Exogenous Compound Tracking: Determination of the metabolic fate and bioavailability of the administered phytocompound (Glucoraphanin/Sulforaphane).
Targeted Plasma Metabolomics: Quantitative analysis of essential amino acids (Tryptophan, Tyrosine, Phenylalanine) and their catabolites.
Microbiota-Derived Metabolites: Assessment of Short-Chain Fatty Acids (SCFAs) and Medium-Chain Fatty Acids (MCFAs) in plasma as indicators of gut microbiota modulation.
Urinary Endogenous Metabolites: Evaluation of changes in the urinary metabolic fingerprint to identify biomarkers of response to treatment.
Measured: baseline and 6 months (end of treatment)
Transcriptomic Profile and Differential Gene Expression Analysis for PD,MS and pediatric patients.
Evaluation of gene expression changes in response to the study treatment. RNA sequencing (RNA-seq) will be performed using Illumina platforms. The bioinformatics pipeline includes:Data Quality Control: FastQC for raw data assessment. Preprocessing: Trimmomatic for adapter trimming and quality filtering.Alignment: STAR aligner against the GRCh38 human reference genome.
Quantification: Transcript counting via the HTSeq-count package. Differential Expression: Identification of Differentially Expressed Genes (DEGs) using the DESeq2 library in R. Statistical analysis: To ensure robustness, false positives will be controlled using the Benjamini-Hochberg post-hoc procedure with a significance threshold (q-value) set at 0.05.
Measured: baseline and 6 months (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 2026Feb 2027

First posted22 Jan 2026
Study start29 Jan 2026
Primary completion14 Oct 2026
Study completionFeb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07360977
Sponsor's protocol ID: GRA-MYR-ND
Other IDs: PNRR-POC-2022-12376049
Acronym: GRA-MYR-ND
Status last verified: Nov 2026
First submitted: 18 Dec 2025
Last updated: 5 Nov 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Deuschl G, Beghi E, Fazekas F, Varga T, Christoforidi KA, Sipido E, Bassetti CL, Vos T, Feigin VL. The burden of neurological diseases in Europe: an analysis for the Global Burden of Disease Study 2017. Lancet Public Health. 2020 Oct;5(10):e551-e567. doi: 10.1016/S2468-2667(20)30190-0.
PubMed 33007212
Klomparens EA, Ding Y. The neuroprotective mechanisms and effects of sulforaphane. Brain Circ. 2019 Apr-Jun;5(2):74-83. doi: 10.4103/bc.bc_7_19. Epub 2019 Jun 27.
PubMed 31334360
Yadav SK, Soin D, Ito K, Dhib-Jalbut S. Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis. J Mol Med (Berl). 2019 Apr;97(4):463-472. doi: 10.1007/s00109-019-01761-5. Epub 2019 Feb 28.
PubMed 30820593
Kamal RM, Abdull Razis AF, Mohd Sukri NS, Perimal EK, Ahmad H, Patrick R, Djedaini-Pilard F, Mazzon E, Rigaud S. Beneficial Health Effects of Glucosinolates-Derived Isothiocyanates on Cardiovascular and Neurodegenerative Diseases. Molecules. 2022 Jan 19;27(3):624. doi: 10.3390/molecules27030624.
PubMed 35163897
Schepici G, Bramanti P, Mazzon E. Efficacy of Sulforaphane in Neurodegenerative Diseases. Int J Mol Sci. 2020 Nov 16;21(22):8637. doi: 10.3390/ijms21228637.
PubMed 33207780
Lotti C, Rubert J, Fava F, Tuohy K, Mattivi F, Vrhovsek U. Development of a fast and cost-effective gas chromatography-mass spectrometry method for the quantification of short-chain and medium-chain fatty acids in human biofluids. Anal Bioanal Chem. 2017 Sep;409(23):5555-5567. doi: 10.1007/s00216-017-0493-5. Epub 2017 Jul 17.
PubMed 28717897
Garcia-Aloy M, Ulaszewska M, Franceschi P, Estruel-Amades S, Weinert CH, Tor-Roca A, Urpi-Sarda M, Mattivi F, Andres-Lacueva C. Discovery of Intake Biomarkers of Lentils, Chickpeas, and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine. Mol Nutr Food Res. 2020 Jul;64(13):e1901137. doi: 10.1002/mnfr.201901137. Epub 2020 Jun 22.
PubMed 32420683
Ulaszewska, M.M., Trost, K., Stanstrup, J. et al. Urinary metabolomic profiling to identify biomarkers of a flavonoid-rich and flavonoid-poor fruits and vegetables diet in adults: the FLAVURS trial
Anesi A, Berding K, Clarke G, Stanton C, Cryan JF, Caplice N, Ross RP, Doolan A, Vrhovsek U, Mattivi F. Metabolomic Workflow for the Accurate and High-Throughput Exploration of the Pathways of Tryptophan, Tyrosine, Phenylalanine, and Branched-Chain Amino Acids in Human Biofluids. J Proteome Res. 2022 May 6;21(5):1262-1275. doi: 10.1021/acs.jproteome.1c00946. Epub 2022 Apr 5.
PubMed 35380444

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

All PARKINSON DISEASE (Disorder) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Composition Comprising Glucoraphanin, Myrosinase and a Buffered Solution for Use in the Treatment of Neurodegenerative Diseases
ClinicalTrials.gov ID: NCT07360977
Acronym / sponsor ID: GRA-MYR-ND / GRA-MYR-ND
Conditions: PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting, Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases
Keywords: phytocompounds, Glucosinolates, isothiocyanate, Parkinson's disease, multiple sclerosis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
Collaborators: Fondazione Edmund Mach, Vittore Buzzi Children's Hospital, Azienda Sanitaria Provinciale Ragusa
Study start: 29 Jan 2026 (actual)
Primary completion: 14 Oct 2026 (actual)
Study completion: Feb 2027 (estimated)
First posted: 22 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
PD patients receiving only standard therapy	No intervention	–Patients affected by Parkinson's disease receiving only standard therapy
PD patients receiving bioactivated GRA	Experimental	Drug: bioactivated GRA for adult patientsPatients affected by Parkinson's disease receiving bioactivated GRA
MS patients receiving only standard therapy	No intervention	–Patients affected by multiple sclerosis receiving only standard therapy
MS patients receiving bioactivated GRA	Experimental	Drug: bioactivated GRA for adult patientsPatients affected by multiple sclerosis receiving bioactivated GRA
Pediatric patients receiving only standard therapy	No intervention	–Pediatric patients receiving only standard therapy
Pediatric patients receiving bioactivated GRA	Experimental	Drug: bioactivated GRA for pediatric patientsPediatric patients receiving bioactivated GRA

Who may qualify

Ages: 1 year to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (16 listed)

Male or female patients aged between 45-75 years old.
Clinical diagnosis of PD according to UK Brain Bank Criteria.
3 months of clinical stability before study enrolment.
Anti-parkinsonian medication is fixed for at least 3 months prior to study entry.
Male or female patients 18 years old or older.

Key exclusion criteria (5 listed)

Absolute contraindications to Magnetic Resonance Imaging (MRI).
Concomitant neurological disease or severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia, or other central nervous system diseases such as stroke, epilepsy or psychiatric disorders;
Total score of Mini-Mental State Examination (MMSE)<24.
Participating in other clinical trials.
Pregnant/lactating.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bioactivated GRA for adult patientsadult dose: 50 mg/day of bioactivated GRA for 6 months	Drug	MS patients receiving bioactivated GRA, PD patients receiving bioactivated GRA
bioactivated GRA for pediatric patientspediatric dose: 10 mg/day of bioactivated GRA for 6 months	Drug	Pediatric patients receiving bioactivated GRA

Primary outcome

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Time frame: Baseline, 6 months (end of treatment), 12 months
The score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. The scale is divided into four parameters: 0 (normal), 1 (mild), 2 (mild), 3 (moderate), and 4 (severe).
Hoehn and Yahr scale
Time frame: Baseline, 6 months (end of treatment), 12 months
Parkinson's Disease Progression Stage Scale (Stage 1 to 5). The scale is a subset of the Unified Parkinson's Disease Rating Scale, which allows for a more nuanced assessment of daily activities and non-motor symptoms in the context of disease therapy.
Expanded Disability Status Scale (EDSS) for Multiple Sclerosis patients
Time frame: Baseline, 6 months (end of treatment), 12 months
Evaluation of the degree of neurological disability in Multiple Sclerosis. The range of the EDSS Step includes 20 half steps from 0 to 10, with EDSS Step 0 corresponding to a completely normal examination and EDSS Step 10 to death due to MS
Cognitive and Neuropsychological Assessments: Montreal Cognitive Assessment (MoCA) and Mini-mental state examination
Time frame: Baseline, 6 months (end of treatment), 12 months
The MoCA is a one-page 30-point test administered in approximately 10 minutes to dectect cognitive impairment. Scores range between 0 and 30, a score of 26 or over is considered to be normal. The mini-mental state examination (MMSE) or Folstein test is a 30-point test to identify cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age
Brief Repeatable Battery (BRB) of Neuropsychological Tests for Multiple Sclerosis patients
Time frame: Baseline, 6 months (end of treatment), 12 months
THE BRB consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory). Higher values represent a better outcome.
Normalized Brain Volume (NBV)
Time frame: Baseline, 6 months (end of treatment), 12 months
Evaluation of global brain atrophy through the measurement of total brain volume normalized for head size using high-field Magnetic Resonance Imaging (MRI). Higher values indicate better brain volume preservation, while a decrease over time indicates progression of brain atrophy.
Normalized Cortical Volume (NCV)
Time frame: Baseline, 6 months (end of treatment), 12 months
Evaluation of regional atrophy focusing on the cerebral cortex. Measurement of cortical gray matter volume normalized for head size using high-field MRI. This parameter is used to quantify the loss of cortical tissue specifically.
Change from Baseline in Whole-Brain Fractional Anisotropy (FA) in Multiple Sclerosis Patients
Time frame: Baseline, 6 months (end of treatment), 12 months
FA is a DTI-derived metric that reflects the microstructural integrity of white matter. In Multiple Sclerosis, a reduction in FA values is a marker of axonal damage and demyelination, even in Normal Appearing White Matter (NAWM).The unit of measurement is the Ratio (Scale from 0 to 1, where 1 indicates maximum diffusion/directional integrity.
Change from Baseline in Whole-Brain Mean Diffusivity (MD) in Multiple Sclerosis patients
Time frame: Baseline, 6 months (end of treatment), 12 months
MD measures the average magnitude of water diffusion. An increase in MD values in MS patients indicates loss of structural barriers, typically due to neurodegeneration, inflammation, or loss of myelin. This parameter provides a global index of tissue destruction.
Non-Motor Symptoms Scale (NMSS) for Parkinson patients
Time frame: Baseline, 6 months (end of treatment), 12 months
It assesses 30 non motor symptoms across 9 domains, with scores ranging from 0 (no symptoms) to 12 per group (severity x frequency), resulting in a total score of 0 to 360, indicating the extent of the non-motor symptom burden. Lower score indicate fewer symptoms; a negative change from baseline indicates improvement in symptoms. Mean scores vary with disease severity, reflecting increased problems with sleep disturbances, mood, cognition, gastrointestinal function, etc.
Quality of Life Assessment: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale.
Time frame: Baseline, 6 months (end of treatment), 12 months
Depression severity is assessed using the 17-item Hamilton Rating Scale for Depression (HRSD). Based on the total score, participants will be classified into the following levels: no depression (0-7), mild depression (8-13), moderate depression (14-18), severe depression (19-22), and very severe depression (≥23). The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire to evaluate the anxiety. The Hamilton Anxiety Rating Scale (HAM-A), which consists of 14 items, each rated on a 5-point scale. The total score, obtained by adding the individual items, ranges from 0 to 56. A score ≤17 indicates mild anxiety; 18-24 indicates mild to moderate anxiety; 25-30 indicates moderate to severe anxiety.
Parkinson's Disease Quality of Life Questionnaire (PDQ-8)
Time frame: Baseline, 6 months (end of treatment), 12 months
It is a patient-reported outcome measure consisting of 8 items that assesses health-related quality of life in Parkinson's disease. It includes one representative item for each domain of the original PDQ-39: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort. Participants rate their experiences in the previous month using a 5-point Likert scale (0 = never to 4 = always). The total score is converted into a Summary Index (SI) ranging from 0 to 100, with higher scores indicating poorer health-related quality of life.Summary Index scores were interpreted as follows: 0-20 indicating good quality of life with minimal disease impact, 21-40 mild impairment, 41-60 moderate impairment, 61-80 marked impairment, and 81-100 severe impairment of quality of life.
Parkinson's Disease Sleep Scale (PDSS-2)
Time frame: Baseline, 6 months (end of treatment), 12 months
The PDSS-2 is a 15-item self-administered questionnaire used to evaluate sleep disturbances and nocturnal symptoms in patients with Parkinson's Disease. It covers various domains including motor symptoms at night, sleep quality, and daytime sleepiness. Each item is scored on a 5-point Likert scale from 0 (never) to 4 (very often). The total score ranges from 0 to 60. A total score ≥ 15-18 is often considered indicative of clinically significant sleep disturbance.
Change from Baseline in EuroQol-5D-3L Index Score
Time frame: Baseline, 6 months (end of treatment), 12 months
The EQ-5D-3L is a standardized instrument for measuring health-related quality of life. It consists of a questionnaire with 5 item: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. These responses are converted into a single index score (utility value) using a country-specific value set.
Clinical Global Impression of Improvement (CGI-I)
Time frame: Baseline, 6 months (end of treatment), 12 months
The CGI-I is a clinician-rated scale that assesses how much the patient's illness has improved or worsened relative to a baseline state.It is scored on a 7-point Likert scale: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment
Patient Global Impression of Change (PGI-C)
Time frame: Baseline, 6 months (end of treatment), 12 months
The PGI-C is a self-reported scale reflecting the patient's belief about the efficacy of treatment and their overall change in health status since the start of the study. It uses a 7-point scale where: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.

7 secondary outcomes

Changes in growth parameters, anthropometric measurements and pubertal status.
Time frame: Baseline, 3 , 6 (end of the treatment) , and 12 months
Changes in Electroencephalogram (EEG) Mean Frequency and Brain Electrical Activity.
Time frame: Baseline, 3, 6 ( end of the treatment), 12 months
Assessment of Swallowing Function via Dysphagia Outcome and Severity Scale (DOSS) in pediatric patients.
Time frame: baseline and 3, 6, 12 months
Changes in Psychomotor Development via Griffiths Mental Development Scales 3 (GMDS-3)
Time frame: baseline and 3, 6, 12 months.
Pediatric Esophageal Motility and Dysphagia Assessment via High-Resolution Manometry (HRM).
Time frame: baseline and 3, 6 ( end of the treatment), 12 months
Metabolomics and Pharmacokinetic Analysis of Bioactive Compounds and Endogenous Metabolites in pediatric, PD and MS patients
Time frame: baseline and 6 months (end of treatment)
Transcriptomic Profile and Differential Gene Expression Analysis for PD,MS and pediatric patients.
Time frame: baseline and 6 months (end of treatment)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Background: PubMed 33007212Deuschl G, Beghi E, Fazekas F, Varga T, Christoforidi KA, Sipido E, Bassetti CL, Vos T, Feigin VL. The burden of neurological diseases in Europe: an analysis for the Global Burden of Disease Study 2017. Lancet Public Health. 2020 Oct;5(10):e551-e567. doi: 10.1016/S2468-2667(20)30190-0.
Background: PubMed 31334360Klomparens EA, Ding Y. The neuroprotective mechanisms and effects of sulforaphane. Brain Circ. 2019 Apr-Jun;5(2):74-83. doi: 10.4103/bc.bc_7_19. Epub 2019 Jun 27.
Background: PubMed 30820593Yadav SK, Soin D, Ito K, Dhib-Jalbut S. Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis. J Mol Med (Berl). 2019 Apr;97(4):463-472. doi: 10.1007/s00109-019-01761-5. Epub 2019 Feb 28.
Background: PubMed 35163897Kamal RM, Abdull Razis AF, Mohd Sukri NS, Perimal EK, Ahmad H, Patrick R, Djedaini-Pilard F, Mazzon E, Rigaud S. Beneficial Health Effects of Glucosinolates-Derived Isothiocyanates on Cardiovascular and Neurodegenerative Diseases. Molecules. 2022 Jan 19;27(3):624. doi: 10.3390/molecules27030624.
Background: PubMed 33207780Schepici G, Bramanti P, Mazzon E. Efficacy of Sulforaphane in Neurodegenerative Diseases. Int J Mol Sci. 2020 Nov 16;21(22):8637. doi: 10.3390/ijms21228637.
Background: PubMed 28717897Lotti C, Rubert J, Fava F, Tuohy K, Mattivi F, Vrhovsek U. Development of a fast and cost-effective gas chromatography-mass spectrometry method for the quantification of short-chain and medium-chain fatty acids in human biofluids. Anal Bioanal Chem. 2017 Sep;409(23):5555-5567. doi: 10.1007/s00216-017-0493-5. Epub 2017 Jul 17.
Background: PubMed 32420683Garcia-Aloy M, Ulaszewska M, Franceschi P, Estruel-Amades S, Weinert CH, Tor-Roca A, Urpi-Sarda M, Mattivi F, Andres-Lacueva C. Discovery of Intake Biomarkers of Lentils, Chickpeas, and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine. Mol Nutr Food Res. 2020 Jul;64(13):e1901137. doi: 10.1002/mnfr.201901137. Epub 2020 Jun 22.
BackgroundUlaszewska, M.M., Trost, K., Stanstrup, J. et al. Urinary metabolomic profiling to identify biomarkers of a flavonoid-rich and flavonoid-poor fruits and vegetables diet in adults: the FLAVURS trial
Background: PubMed 35380444Anesi A, Berding K, Clarke G, Stanton C, Cryan JF, Caplice N, Ross RP, Doolan A, Vrhovsek U, Mattivi F. Metabolomic Workflow for the Accurate and High-Throughput Exploration of the Pathways of Tryptophan, Tyrosine, Phenylalanine, and Branched-Chain Amino Acids in Human Biofluids. J Proteome Res. 2022 May 6;21(5):1262-1275. doi: 10.1021/acs.jproteome.1c00946. Epub 2022 Apr 5.
Individual participant dataSharing planned: No

Related trials for PARKINSON DISEASE (Disorder)

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emanuela Mazzon principal investigator

IRCCS Centro Neurolesi Bonino Pulejo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (time frame: Baseline, 6 months (end of treatment), 12 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07360977, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.