Parkinson DiseasePARK001NCT03960242
Evaluation of Clinical Progression in Patients With Motor Predominant Parkinson Disease.
An observational study of Parkinson Disease, run by BrainEver at 2 sites in France.
Trial summary
The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 3 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jan 2019to 18 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with motor predominant PD aged 70 or less, with a disease onset between 2-8 years.
Who may be able to join
- Idiopathic Parkinson's Disease (According to British Brain Bank Criteria); genetic forms of PD are not excluded
- Male or female adult, aged 70 or less
- Modified Hoehn and Yahr stage 2 to 3 in OFF state
- Disease duration, i.e. time from first motor symptoms between 2 to 8 (included) years ; first motor symptoms to be taken into consideration being the cardinal motor symptoms of PD (bradykinesia, tremor and rigidity)
- Univoqual response to L-DOPA (of at least 50% in MDS-UPDRS Part III motor score)
- Presence of fluctuations and/or dyskinesia
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- MDS-UPDRS total motor score ≥15 in OFF state
- L-Dopa treatment stable for at least 4 weeks
- Covered by healthcare insurance
- Written informed consent form signed
Who cannot join
- Scan Without Evidence of Dopamine Deficit (SWEDD) (DaTSCAN)
- Atypical parkinsonism syndrome
- Dementia as detected by a score < 21/30 at the Montreal Cognitive Assessment Screening (MoCA)
- Psychiatric disorders including major depression with suicidal thoughts as evaluated by a psychiatrist or a neurologist at the selection period
- Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
- History of significant brain or vascular disease (tumor, epilepsy, stroke …)
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- Any contraindication for undergoing MRI of the head
- Prior brain surgical procedures with or without implementation of an intra-cerebral device
- Drug or alcohol addiction
- Pregnancy or breastfeeding
- Patient with reproductive potential who do not agree to use an accepted effective method of contraception - investigator's judgment- during the study period
- Illiteracy or insufficient language skills (French) to complete the questionnaires
- Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
- Simultaneous participation in another clinical trial with the administration of investigational drug(s)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.
The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.
Read the detailed description
The absence of clear PD subtypes defining a common path and rate of disease progression, combined with the absence of validated biomarkers indicative of disease progression and a strong placebo effect, constitute a challenge for clinical trials assessing new potential disease-modifying therapies in PD.
The present cohort would constitute a well-defined population of patients, with individual progression assessment, suitable to evaluate new disease-modifying therapies in a subsequent Phase1/2 clinical trial.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications
An examiner will measure MDS-UPDRS part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates each motor symptom based on a scale of 0 - 4, higher values indicating worse function.
Measured: baseline, 6, 12, 18, 24 and 30 months after baseline ]
Secondary outcomes (1)
Change from Baseline of brain MRI
neuromelanin sequence
Measured: 12 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 posted23 May 2019
- Study start14 Jan 2019
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
Why it stopped: Programs strategy refining due to Covid crisis
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainEver
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960242
- Sponsor's protocol ID
- BREN01_CLIN_001
- Acronym
- PARK001
- Status last verified
- Dec 2022
- First submitted
- 10 May 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.
- ClinicalTrials.gov ID
- NCT03960242
- Acronym / sponsor ID
- PARK001 / BREN01_CLIN_001
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Programs strategy refining due to Covid crisis
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BrainEverIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 23 May 2019 (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.
The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.
Detailed description
The absence of clear PD subtypes defining a common path and rate of disease progression, combined with the absence of validated biomarkers indicative of disease progression and a strong placebo effect, constitute a challenge for clinical trials assessing new potential disease-modifying therapies in PD.
The present cohort would constitute a well-defined population of patients, with individual progression assessment, suitable to evaluate new disease-modifying therapies in a subsequent Phase1/2 clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with motor predominant PD aged 70 or less, with a disease onset between 2-8 years.
Key inclusion criteria (10 listed)
- Idiopathic Parkinson's Disease (According to British Brain Bank Criteria); genetic forms of PD are not excluded
- Male or female adult, aged 70 or less
- Modified Hoehn and Yahr stage 2 to 3 in OFF state
- Disease duration, i.e. time from first motor symptoms between 2 to 8 (included) years ; first motor symptoms to be taken into consideration being the cardinal motor symptoms of PD (bradykinesia, tremor and rigidity)
- Univoqual response to L-DOPA (of at least 50% in MDS-UPDRS Part III motor score)
Key exclusion criteria (14 listed)
- Scan Without Evidence of Dopamine Deficit (SWEDD) (DaTSCAN)
- Atypical parkinsonism syndrome
- Dementia as detected by a score < 21/30 at the Montreal Cognitive Assessment Screening (MoCA)
- Psychiatric disorders including major depression with suicidal thoughts as evaluated by a psychiatrist or a neurologist at the selection period
- Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
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 from baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications
Time frame: baseline, 6, 12, 18, 24 and 30 months after baseline ]
An examiner will measure MDS-UPDRS part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates each motor symptom based on a scale of 0 - 4, higher values indicating worse function.
1 secondary outcome
Change from Baseline of brain MRI
Time frame: 12 and 24 months
Results and safety
The study was stopped early (reason given: Programs strategy refining due to Covid crisis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by BrainEver at 2 sites in France.
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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was stopped early (reason given: Programs strategy refining due to Covid crisis). Results are not available in the source record.
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 from baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications (time frame: baseline, 6, 12, 18, 24 and 30 months after baseline ]). 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 21 Dec 2022.