Parkinson DiseasePhase 2LIBRANCT06431971
Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
A Phase 2 study testing Talineuren in people with Parkinson Disease, run by InnoMedica Schweiz AG at 6 sites in Switzerland.
Trial summary
This study is double-blinded placebo controlled followed by an open-label extension placebo-to-active switch to estimate the efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 48 times intravenously as an add-on therapy to the standard of care Parkinson medication. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Talineuren
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Jan 2027to Jul 2028
- Phase
- Phase 2
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature.
- Male and female subjects, aged 30 to 85 years.
- Confirmed PD according to British brain bank criteria.
- Hoehn and Yahr Stage 0 - 2.5 on medication and on stimulation (DBS, if applicable).
- Stable dopaminergic PD treatment (including DBS) for a month at least.
- Absence of dementia confirmed by cognitive testing (MoCA ≥24).
Who cannot join
- Previous treatment with Talineuren (i.e. participants from NEON trial are not allowed)
- Contraindications to the drug classes of standard of care medication and the investigational medicinal product, (e.g., known hypersensitivity or allergy) and contraindications as listed in the product information of marketed products.
- Known / suspected diagnosis of hereditary fructose intolerance.
- Prior Campylobacter-jejuni-gastroenteritis or prior occurrence of Guillain-Barré-Syndrome.
- Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 12 weeks following the trial.
- Lack of safe contraception, defined as: Female participants of childbearing potential, not willing to use double method of contraception (hormonal and mechanical) for the entire study duration. Note: Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
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- Male participants, not using and not willing to use a medically reliable method of contraception for the entire study duration, such as condoms or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Inability to follow the procedures of the trial, e.g., due to language problems, psychological disorders etc. of the participant.
- Participation in another trial with an investigational drug within the 30 days preceding and during the present trial.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- Subject has an atypical parkinsonian syndrome or secondary parkinsonism.
- Patients in adjustment of deep brain stimulation (DBS) parameters
- Patients with clinically significant concomitant diseases (e.g., renal failure, hepatic dysfunction, cardiovascular disease, infections, etc.) that are not under stable control.
- Known or suspected non-compliance, drug or alcohol abuse.
- Patients with comorbidity that may interfere with the course of the trial.
- Patients with an established diagnosis of clinically relevant bone marrow dysfunction affecting leukopoiesis or with active hematological malignancies or with a clinically relevant immunodeficiency.
- Concomitant use of myelotoxic (e.g. cytostatic agents) and/or other drugs with clinically relevant immunosuppressive effects (e.g. calcineurin inhibitors) and/or drugs associated with a clinically relevant impairment of granulopoiesis.
- Patients who are not considered to be eligible to participate in clinical trial by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Switzerland6 sites
Kantonsspital Aarau (KSA), Neurologische Klinik
Aarau, Canton of Aargau, 5001
Tobias Piroth, Dr. med.
Hôpitaux Universitaires de Genève (HUG), Département des Neurosciences cliniques NEUCLI, Service de Neurologie
Geneva, Canton of Geneva, 1205
Vanessa Fleury, Dr.
Neurologisches Institut Konolfingen
Konolfingen, 3510
Michael Schüpbach, Dr. med., +41 31 790 01 30, nik@hin.ch
Michael Schüpbach, Dr. med
Centre hospitalier universitaire Vaudois (CHUV), Clinical Neurosciences Department
Lausanne, Canton of Vaud, 1011
Julien Bally, Dr.
Health Ostschweiz/ Kantonsspital St. Gallen (KSSG), Klinik für Neurologie
Sankt Gallen, Canton of St. Gallen, 9007
Florian Brugger, PD Dr. med.
Bellevue Medical Group AG (BMG), Neurozentrum Seefeld
Zurich, Canton of Zurich, 8008
Kerstin Schweyer, Dr. med.
About this study
Official title: Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease: A Randomized, Placebo-controlled, Double-blinded, Parallel 2-arm, With Open-label Extension Placebo-to-active Switch, Multi-centre Phase I/IIa Trial
This study is double-blinded placebo controlled followed by an open-label extension placebo-to-active switch to estimate the efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 48 times intravenously as an add-on therapy to the standard of care Parkinson medication.
Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.
Read the detailed description
The ganglioside lipid GM1 (monosialotetrahexosylganglioside) has attracted attention in scientific literature as a promising neuroprotective agent. Research suggests that GM1 ganglioside holds promise not only in the treatment of neurodegenerative disorders like Parkinson disease (PD) and Alzheimer's disease but also in promoting nerve regeneration post-injury. Furthermore, investigations into its potential to improve cognitive function and memory underscore its versatility as a therapeutic agent. Numerous clinical studies have demonstrated its therapeutic potential in treating (PD) patients.
Talineuren (TLN) represents a novel approach to harnessing the therapeutic benefits of GM1. TLN is a liposomal formulation, comprising GM1 as its pharmacologically active ingredient, which is expected to cross the blood-brain barrier more efficiently as free GM1 and therefore is able to deliver more GM1 to the brain. This innovative composition is designed to optimize the neuroprotective effects of GM1.
Study Description:
This study is designed as a double-blinded, placebo-controlled trial with open-label placebo-to-active switch to evaluate the efficacy of TLN in PD management. The investigational Medicinal Product (IMP), TLN, is weekly intravenously administered a maximum of 48 times as an add-on therapy alongside patients' current standard-of-care PD medication. Talineuren, encapsulating GM1 within liposomes, is anticipated to facilitate enhanced delivery and bioavailability of the neuroprotective agent, GM1.
Objectives:
The primary objective is to estimate differences between PD patients treated with Talineuren and those receiving placebo regarding their average MDS-UPDRS part III score in the defined "off" medication state (part of the Levodopa challenge test (LCT); motor symptoms evaluated by a physician) over a study period of 6 months.
Secondary objectives are to obtain the change from baseline and variance of TLN and placebo and compare these between the groups for :
- MDS-UPDRS total score (part I + part II + part III "off" + part IV)
- MDS-UPDRS part I (non-motor symptoms in daily life)
- MDS-UPDRS part II (motor symptoms in daily life)
- MDS-UPDRS part III "on medication"
- MDS-UPDRS total part IV (motor complications)
- Proportion of patients meeting or exceeding the minimum clinically important difference (MCID) in motor and non-motor symptoms (MDS-UPDRS) and quality of life (PDQ-39) over time
- Quality of life (PDQ-39, EQ-5D-5L)
- Mental condition (MoCA)
- Parkinson medication (LEDD)
- Digital biomarker: voice analysis
Research objectives (biomarkers):
-Assessment of literature-described biomarkers (prognostic, predictive, monitoring and/or response biomarkers) pre- and post-TLN or placebo intervention.
Through evaluation and statistical analysis, this study seeks to elucidate the therapeutic potential of TLN in addressing the multifaceted challenges of Parkinson's disease. By providing insights into treatment efficacy, medication usage, symptom management, and quality of life improvements, our findings aim to inform future advancements in PD management and enhance patient care.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.
- Conditions
- Parkinson Disease
- Being tested
- Talineuren, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalineurenDrug
Also called TLN, Liposomal GM1
Talineuren infusion weekly
PlaceboDrug
Also called 0.9% NaCl
Placebo infusion weekly
| Study group | Role | What they receive |
|---|---|---|
| Talineuren | Experimental | Participants receive standard of care PD treatment + Talineuren i.v. weekly starting with a dose escalation of 12 mg, 60 mg and 360 mg Talineuren followed by 720 mg Talineuren for 21 weeks (24 infusions, 24 weeks in total) during the double-blind phase. Participants may continue in an open-label extension phase and receive 720 mg of Talineuren i.v. weekly for additional 24 infusions (24 weeks). Receives: Drug: Talineuren |
| Placebo | Placebo comparator | Participants receive standard of care PD treatment + placebo (0.9% NaCl) i.v. weekly for 24 infusions (24 weeks) in the double-blind phase. Participants may continue in an open-label extension phase and will receive Talineuren i.v. weekly starting with a dose escalation of 12 mg, 60 mg and 360 mg Talineuren followed by 720 mg Talineuren for 21 infusions (24 infusions, 24 weeks in total). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society Unified Parkinson's Disease Rating Scale score
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used by the patient and physician to evaluate various symptoms of Parkinson disease including non-motor and motor experiences of daily living and motor complications.
The MDS-UPDRS Scale consists of 4 parts:
- Part 1 (Nonmotor aspects of experiences of daily living) with 13 items.
- Part 2 (Motor aspects of experiences of daily living) with 13 items.
- Part 3 (Motor examination) with 18 items.
- Part 4 (Motor complications) with 6 items.
Each item is rated with 0=normal, 1=slight, 2=mild, 3=moderate, 4=severe. The lower the score, the fewer / less severe the symptoms.
Measured: Baseline, week 25 (primary endpoint)
Secondary outcomes (6)
Parkinson disease Quality of Life Questionnaire score
Parkinson disease Quality of Life Questionnaire (PDQ-39) will be completed by the patient. The proportion of patients reaching or exceeding the minimal clinical important difference (MCID) will be assessed.
This questionnaire consists of 39 items in 8 dimensions with 0 = perfect health, 100 = worse health.
Measured: Baseline, week 25, week 49
Montreal Cognitive Assessment score
Patient's mental condition is assessed using the Montreal Cognitive Assessment (MoCA) by the physician together with the patient where the patient can reach a score of 0-30. A final total score of 26 and above is considered normal.
Measured: Baseline, week 25, week 49
Change in Levodopa equivalent daily dose
Levodopa equivalent daily dose (LEDD) in [mg] will documented at each study visit.
Measured: Through study completion, an average of 56 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale score
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used by the patient and physician to evaluate various symptoms of Parkinson disease including non-motor and motor experiences of daily living and motor complications.
The MDS-UPDRS Scale consists of 4 parts:
- Part 1 (Nonmotor aspects of experiences of daily living) with 13 items.
- Part 2 (Motor aspects of experiences of daily living) with 13 items.
- Part 3 (Motor examination) with 18 items.
- Part 4 (Motor complications) with 6 items.
Each item is rated with 0=normal, 1=slight, 2=mild, 3=moderate, 4=severe. The lower the score, the fewer / less severe the symptoms.
Measured: Baseline, week 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53
EQ-5D-5L
The EQ-5D-5L is a standardized, preference-based instrument used to assess health-related quality of life in clinical studies. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity ranging from no problems to extreme problems. This structure allows for a detailed description of a participant's health state and improves sensitivity compared to earlier versions. Health states are converted into a single utility index using country-specific value sets, enabling use in economic evaluations such as cost-utility analyses. In addition, the instrument includes a visual analogue scale, where participants rate their overall health on a scale from 0 to 100.
Measured: Baseline, week 25, week 49
Change from Baseline in Voice-Based Disease Severity Prediction Score
Speech samples will be recorded using the Virtuosis AI voice assessment platform. At each assessment, participants will provide a speech recording of at least 30 seconds in response to a standardized question. Automated algorithms will quantify speech features related to voice quality, prosody, articulation, fluency, and speech rate. Based on raw acoustic measures (e.g., dB and Hz), corresponding z-scores, and their position relative to Parkinson's disease-specific thresholds, an overall voice score will be generated. Changes in the overall voice score over time will be assessed.
Measured: Baseline to week 53 (measured twice weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoMedica Schweiz AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431971
- Sponsor's protocol ID
- LIBRA (TLN/PD/2)
- Acronym
- LIBRA
- Status last verified
- Oct 2026
- First submitted
- 16 May 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease: A Randomized, Placebo-controlled, Double-blinded, Parallel 2-arm, With Open-label Extension Placebo-to-active Switch, Multi-centre Phase I/IIa Trial
- ClinicalTrials.gov ID
- NCT06431971
- Acronym / sponsor ID
- LIBRA / LIBRA (TLN/PD/2)
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- InnoMedica Schweiz AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 May 2024 (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.
This study is double-blinded placebo controlled followed by an open-label extension placebo-to-active switch to estimate the efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 48 times intravenously as an add-on therapy to the standard of care Parkinson medication.
Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.
Detailed description
The ganglioside lipid GM1 (monosialotetrahexosylganglioside) has attracted attention in scientific literature as a promising neuroprotective agent. Research suggests that GM1 ganglioside holds promise not only in the treatment of neurodegenerative disorders like Parkinson disease (PD) and Alzheimer's disease but also in promoting nerve regeneration post-injury. Furthermore, investigations into its potential to improve cognitive function and memory underscore its versatility as a therapeutic agent. Numerous clinical studies have demonstrated its therapeutic potential in treating (PD) patients.
Talineuren (TLN) represents a novel approach to harnessing the therapeutic benefits of GM1. TLN is a liposomal formulation, comprising GM1 as its pharmacologically active ingredient, which is expected to cross the blood-brain barrier more efficiently as free GM1 and therefore is able to deliver more GM1 to the brain. This innovative composition is designed to optimize the neuroprotective effects of GM1.
Study Description:
This study is designed as a double-blinded, placebo-controlled trial with open-label placebo-to-active switch to evaluate the efficacy of TLN in PD management. The investigational Medicinal Product (IMP), TLN, is weekly intravenously administered a maximum of 48 times as an add-on therapy alongside patients' current standard-of-care PD medication. Talineuren, encapsulating GM1 within liposomes, is anticipated to facilitate enhanced delivery and bioavailability of the neuroprotective agent, GM1.
Objectives:
The primary objective is to estimate differences between PD patients treated with Talineuren and those receiving placebo regarding their average MDS-UPDRS part III score in the defined "off" medication state (part of the Levodopa challenge test (LCT); motor symptoms evaluated by a physician) over a study period of 6 months.
Secondary objectives are to obtain the change from baseline and variance of TLN and placebo and compare these between the groups for :
- MDS-UPDRS total score (part I + part II + part III "off" + part IV)
- MDS-UPDRS part I (non-motor symptoms in daily life)
- MDS-UPDRS part II (motor symptoms in daily life)
- MDS-UPDRS part III "on medication"
- MDS-UPDRS total part IV (motor complications)
- Proportion of patients meeting or exceeding the minimum clinically important difference (MCID) in motor and non-motor symptoms (MDS-UPDRS) and quality of life (PDQ-39) over time
- Quality of life (PDQ-39, EQ-5D-5L)
- Mental condition (MoCA)
- Parkinson medication (LEDD)
- Digital biomarker: voice analysis
Research objectives (biomarkers):
-Assessment of literature-described biomarkers (prognostic, predictive, monitoring and/or response biomarkers) pre- and post-TLN or placebo intervention.
Through evaluation and statistical analysis, this study seeks to elucidate the therapeutic potential of TLN in addressing the multifaceted challenges of Parkinson's disease. By providing insights into treatment efficacy, medication usage, symptom management, and quality of life improvements, our findings aim to inform future advancements in PD management and enhance patient care.
The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talineuren | Experimental | Drug: TalineurenParticipants receive standard of care PD treatment + Talineuren i.v. weekly starting with a dose escalation of 12 mg, 60 mg and 360 mg Talineuren followed by 720 mg Talineuren for 21 weeks (24 infusions, 24 weeks in total) during the double-blind phase. Participants may continue in an open-label extension phase and receive 720 mg of Talineuren i.v. weekly for additional 24 infusions (24 weeks). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive standard of care PD treatment + placebo (0.9% NaCl) i.v. weekly for 24 infusions (24 weeks) in the double-blind phase. Participants may continue in an open-label extension phase and will receive Talineuren i.v. weekly starting with a dose escalation of 12 mg, 60 mg and 360 mg Talineuren followed by 720 mg Talineuren for 21 infusions (24 infusions, 24 weeks in total). |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent as documented by signature.
- Male and female subjects, aged 30 to 85 years.
- Confirmed PD according to British brain bank criteria.
- Hoehn and Yahr Stage 0 - 2.5 on medication and on stimulation (DBS, if applicable).
- Stable dopaminergic PD treatment (including DBS) for a month at least.
Key exclusion criteria (18 listed)
- Previous treatment with Talineuren (i.e. participants from NEON trial are not allowed)
- Contraindications to the drug classes of standard of care medication and the investigational medicinal product, (e.g., known hypersensitivity or allergy) and contraindications as listed in the product information of marketed products.
- Known / suspected diagnosis of hereditary fructose intolerance.
- Prior Campylobacter-jejuni-gastroenteritis or prior occurrence of Guillain-Barré-Syndrome.
- Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 12 weeks following the trial.
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 |
|---|---|---|
| TalineurenAlso: TLN, Liposomal GM1Talineuren infusion weekly | Drug | Talineuren |
| PlaceboAlso: 0.9% NaClPlacebo infusion weekly | Drug | Placebo |
Primary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale score
Time frame: Baseline, week 25 (primary endpoint)
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used by the patient and physician to evaluate various symptoms of Parkinson disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS Scale consists of 4 parts: * Part 1 (Nonmotor aspects of experiences of daily living) with 13 items. * Part 2 (Motor aspects of experiences of daily living) with 13 items. * Part 3 (Motor examination) with 18 items. * Part 4 (Motor complications) with 6 items. Each item is rated with 0=normal, 1=slight, 2=mild, 3=moderate, 4=severe. The lower the score, the fewer / less severe the symptoms.
6 secondary outcomes
Parkinson disease Quality of Life Questionnaire score
Time frame: Baseline, week 25, week 49
Montreal Cognitive Assessment score
Time frame: Baseline, week 25, week 49
Change in Levodopa equivalent daily dose
Time frame: Through study completion, an average of 56 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale score
Time frame: Baseline, week 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53
EQ-5D-5L
Time frame: Baseline, week 25, week 49
Change from Baseline in Voice-Based Disease Severity Prediction Score
Time frame: Baseline to week 53 (measured twice weekly)
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talineuren in people with Parkinson Disease, run by InnoMedica Schweiz AG at 6 sites in Switzerland.
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 6 inclusion and 18 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Florian Peters, PhD (+41 31 311 04 27, info@innomedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society Unified Parkinson's Disease Rating Scale score (time frame: Baseline, week 25 (primary endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.