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

NCT03960242 | Terminated

• 1 other identifier: BREN01_CLIN_001
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 6, 12, 18, 24 and 30 months after baseline ]

Secondary Outcomes (1)

• Change from Baseline of brain MRI

  12 and 24 months

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with motor predominant PD aged 70 or less, with a disease onset between 2-8 years.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 …)
• 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)

Sponsors & Collaborators

• BrainEver: lead

Study Sites (2)

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Pitié-Salpétrière

Paris, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 23, 2019
• Study Start: January 14, 2019
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)