Condition or disease |
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Parkinson 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 |
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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
France | |
Hôpital Henri Mondor | |
Créteil, France | |
Hôpital Pitié-Salpétrière | |
Paris, France |
Tracking Information | |||||
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First Submitted Date | May 10, 2019 | ||||
First Posted Date | May 23, 2019 | ||||
Last Update Posted Date | September 21, 2020 | ||||
Actual Study Start Date | January 14, 2019 | ||||
Estimated Primary Completion Date | October 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures |
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 and 18 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.
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Change History | |||||
Current Secondary Outcome Measures |
Change from Baseline of brain MRI [ Time Frame: 12 and 24 months ] neuromelanin sequence
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Original Secondary Outcome Measures |
Change from Baseline of brain MRI [ Time Frame: 12-months ] neuromelanin sequence
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Evaluation of Clinical Progression in Patients With Motor Predominant Parkinson Disease. | ||||
Official Title | Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease. | ||||
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. | ||||
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 | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patient with motor predominant PD aged 70 or less, with a disease onset between 2-8 years. | ||||
Condition | Parkinson Disease | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Suspended | ||||
Estimated Enrollment |
30 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | October 30, 2022 | ||||
Estimated Primary Completion Date | October 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 70 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03960242 | ||||
Other Study ID Numbers | BREN01_CLIN_001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | BrainEver | ||||
Study Sponsor | BrainEver | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | BrainEver | ||||
Verification Date | September 2020 |