Parkinson's DiseaseNCT05363046
Noninterventional Study Evaluating Parkinson's Disease Diary Use
An observational study of Parkinson's Disease, run by BlueRock Therapeutics at 34 sites in 5 countries.
Trial summary
This study aims to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms. Read more about this study
- Who is it for?
- Ages 39 to 70 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 194 participants
- Where
- 34 sitesin 5 countries
- Study dates
- 29 Jul 2022to Oct 2026
- Phase
- Observational
- 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 39 to 70 years
- All sexes
- Adult, Older adult
Study population: Parkinson's disease patients whose medications do not provide adequate control of their symptoms.
Who may be able to join
- ≥39 to ≤70 years of age at signing of informed consent
- Diagnosis of clinically established PD as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD
- Marked levodopa responsiveness at screening per investigator's judgment (eg, an estimated ≥30% improvement of MDS-UPDRS Part III score in the off-medication versus on-medication state)
- A minimum of 3 years and a maximum of 10 years from time of PD diagnosis to the date of screening
- Receiving optimized and stable PD medical therapy for ≥1 month prior to screening or demonstrated intolerance to PD medications per investigator's judgment in agreement with the medical monitor
- ≥2 hours of average daily OFF-time assessed within 3 months of screening by PD diary or per investigator's judgment
- Hoehn and Yahr Stage of 1 to 3 while on PD medication assessed within 3 months of screening or at screening
- Normal cognition as determined by the investigator after review of relevant testing (eg, Montreal Cognitive Assessment score of ≥26, or ≥22 if no significant cognitive impairment as determined by neuropsychological testing)
Who cannot join
- PD with risk of recurrent falls or only tremor-based symptoms
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD such as Alzheimer's disease
- Any available evidence inconsistent with dopamine deficiency (eg, 18F-DOPA positron emission tomography [PET] or dopamine transporter single-photon emission computed tomography [DAT-SPECT] imaging if performed)
- Moderately severe dyskinesia per investigator's judgment
- Receiving dopamine receptor-blocking agents, including typical neuroleptics, prochlorperazine, and metoclopramide at the time of screening or within 3 months prior to screening
- Treatment with intrajejunal or subcutaneous infusion therapies for PD within 2 months of screening
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- History of gene therapy or cell therapy
- Prior surgical or radiation therapy to the brain, including deep brain stimulation and lesion therapy, or prior history of intradural spinal cord surgery
- Receipt of another investigational therapy or device within 2 years of screening unless approved by the medical monitor
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
United States16 sites
University of Colorado
Aurora, Colorado, 80045
Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Tufts Medical Center
Boston, Massachusetts, 02111
Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
University of Kansas Medical Center
Kansas City, Kansas, 66103
Evergreen Health Medical Center
Kirkland, Washington, 98034
David Geffen School of Medicine University of California Los Angeles
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
University of Miami Health System
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai West
New York, New York, 10019
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10021
University of California, Irvine
Orange, California, 92868
University of Rochester Medical Center
Rochester, New York, 14618
Mayo Clinic Neurology
Scottsdale, Arizona, 85259
Germany8 sites
Universitaetsklinikum Duesseldorf AöR
Düsseldorf, 40225
Klinik und Poliklinik für Neurologie am Standort Marburg
Marburg, Hesse, 35043
Klinikum der Universität München - Campus Grosshadern
Munich, Bavaria, 81377
Technischen Universitaet Muenchen (TUM)
Munich, Bavaria, 81675
Universitätsmedizin Rostock
Rostock, 18147
University Hospital Tuebingen
Tübingen, 72076
Dkd Wiesbaden
Wolfach, Baden-Wurttemberg, 77709
Universitätsklinikum Würzburg - Medizinische Klinik
Würzburg, Bavaria, 97080
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Complexo Hospitalario de Pontevedra (CHOP)
Pontevedra, 36071
Hospital San Juan de Dios
Santurtzi, Bilbao, 48980
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario Y Politécnico La Fe
Valencia, 46026
Italy4 sites
AOU Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, 60126
Azienda Ospedale Università Padova
Padova, 35128
IRCCS San Raffaele Pisana
Rome, 00163
AOU OO.RR. San Giovanni di Dio Ruggi d'Aragona
Salerno, 84131
About this study
Official title: A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary
This study aims to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms.
Read the detailed description
This is a global, multi-center, noninterventional study of patients with PD aged ≥39 to ≤70 years under standard-of-care treatment that will enroll a minimum of approximately 150 participants and up to 400 participants. Participants will be assigned (1:1) to complete the PD diary either on 3 consecutive days in 1 week (Group A) or 2 consecutive days in each of 2 consecutive weeks (Group B) for a given study visit. During the study, data are collected on motor function, quality of life, and use of PD medications at Baseline and at 3, 6, 12, 18, and 24 months.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Participants will complete the PD diary on 3 consecutive days in 1 week. | |
| Group B | Participants will complete the PD diary on 2 consecutive days in each of 2 consecutive weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Good ON-time as measured by the PD Diary.
Standard deviation of change in ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Measured: Baseline, 3, 6, 12, 18 and 24 months.
Individual participant variability for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Within-subject coefficient of variation for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Measured: Baseline, 3, 6, 12, 18 and 24 months.
Proportion of valid PD Diaries.
Proportion of valid PD Diaries.
Measured: Baseline, 3, 6, 12, 18 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start29 Jul 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueRock Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363046
- Sponsor's protocol ID
- BRT-DA01-NIS-001
- Status last verified
- Jul 2024
- First submitted
- 3 May 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary
- ClinicalTrials.gov ID
- NCT05363046
- Acronym / sponsor ID
- BRT-DA01-NIS-001
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 194 participants (actual)
- Lead sponsor
- BlueRock TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 May 2022 (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 aims to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms.
Detailed description
This is a global, multi-center, noninterventional study of patients with PD aged ≥39 to ≤70 years under standard-of-care treatment that will enroll a minimum of approximately 150 participants and up to 400 participants. Participants will be assigned (1:1) to complete the PD diary either on 3 consecutive days in 1 week (Group A) or 2 consecutive days in each of 2 consecutive weeks (Group B) for a given study visit. During the study, data are collected on motor function, quality of life, and use of PD medications at Baseline and at 3, 6, 12, 18, and 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Participants will complete the PD diary on 3 consecutive days in 1 week. |
| Group B | – | –Participants will complete the PD diary on 2 consecutive days in each of 2 consecutive weeks. |
Who may qualify
- Ages
- 39 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients whose medications do not provide adequate control of their symptoms.
Key inclusion criteria (8 listed)
- ≥39 to ≤70 years of age at signing of informed consent
- Diagnosis of clinically established PD as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD
- Marked levodopa responsiveness at screening per investigator's judgment (eg, an estimated ≥30% improvement of MDS-UPDRS Part III score in the off-medication versus on-medication state)
- A minimum of 3 years and a maximum of 10 years from time of PD diagnosis to the date of screening
- Receiving optimized and stable PD medical therapy for ≥1 month prior to screening or demonstrated intolerance to PD medications per investigator's judgment in agreement with the medical monitor
Key exclusion criteria (9 listed)
- PD with risk of recurrent falls or only tremor-based symptoms
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD such as Alzheimer's disease
- Any available evidence inconsistent with dopamine deficiency (eg, 18F-DOPA positron emission tomography [PET] or dopamine transporter single-photon emission computed tomography [DAT-SPECT] imaging if performed)
- Moderately severe dyskinesia per investigator's judgment
- Receiving dopamine receptor-blocking agents, including typical neuroleptics, prochlorperazine, and metoclopramide at the time of screening or within 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Good ON-time as measured by the PD Diary.
Time frame: Baseline, 3, 6, 12, 18 and 24 months.
Standard deviation of change in ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Individual participant variability for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Time frame: Baseline, 3, 6, 12, 18 and 24 months.
Within-subject coefficient of variation for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Proportion of valid PD Diaries.
Time frame: Baseline, 3, 6, 12, 18 and 24 months.
Proportion of valid PD Diaries.
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 31 Jul 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by BlueRock Therapeutics at 34 sites in 5 countries.
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 8 inclusion and 9 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Germany, Spain, Italy, Canada. 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?
Change in Good ON-time as measured by the PD Diary. (time frame: Baseline, 3, 6, 12, 18 and 24 months.). The study lists 3 primary outcomes in all. 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 31 Jul 2024.