Evaluation of Clinical Progression in Patients With Motor Predominant Parkinson Disease. (PARK001)
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|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
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
- 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.
- Change from Baseline of brain MRI [ Time Frame: 12 and 24 months ]neuromelanin sequence
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
|Hôpital Henri Mondor|