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Evaluation of Clinical Progression in Patients With Motor Predominant Parkinson Disease. (PARK001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960242
Recruitment Status : Suspended (Temporary halt of the trial due to COVID-19 crisis related delays)
First Posted : May 23, 2019
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
BrainEver

Brief 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.

Condition or disease
Parkinson Disease

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from Baseline of brain MRI [ Time Frame: 12 and 24 months ]
    neuromelanin sequence



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with motor predominant PD aged 70 or less, with a disease onset between 2-8 years.
Criteria

Inclusion Criteria:

  1. Idiopathic Parkinson's Disease (According to British Brain Bank Criteria); genetic forms of PD are not excluded
  2. Male or female adult, aged 70 or less
  3. Modified Hoehn and Yahr stage 2 to 3 in OFF state
  4. 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)
  5. Univoqual response to L-DOPA (of at least 50% in MDS-UPDRS Part III motor score)
  6. Presence of fluctuations and/or dyskinesia
  7. MDS-UPDRS total motor score ≥15 in OFF state
  8. L-Dopa treatment stable for at least 4 weeks
  9. Covered by healthcare insurance
  10. Written informed consent form signed

Exclusion Criteria:

  1. Scan Without Evidence of Dopamine Deficit (SWEDD) (DaTSCAN)
  2. Atypical parkinsonism syndrome
  3. Dementia as detected by a score < 21/30 at the Montreal Cognitive Assessment Screening (MoCA)
  4. Psychiatric disorders including major depression with suicidal thoughts as evaluated by a psychiatrist or a neurologist at the selection period
  5. Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
  6. History of significant brain or vascular disease (tumor, epilepsy, stroke …)
  7. Any contraindication for undergoing MRI of the head
  8. Prior brain surgical procedures with or without implementation of an intra-cerebral device
  9. Drug or alcohol addiction
  10. Pregnancy or breastfeeding
  11. Patient with reproductive potential who do not agree to use an accepted effective method of contraception - investigator's judgment- during the study period
  12. Illiteracy or insufficient language skills (French) to complete the questionnaires
  13. Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
  14. Simultaneous participation in another clinical trial with the administration of investigational drug(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960242


Locations
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France
Hôpital Henri Mondor
Créteil, France
Hôpital Pitié-Salpétrière
Paris, France
Sponsors and Collaborators
BrainEver
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Responsible Party: BrainEver
ClinicalTrials.gov Identifier: NCT03960242    
Other Study ID Numbers: BREN01_CLIN_001
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases