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

Parkinson Disease Clinical Trial

— PARK001  

Official title:

Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03960242
• Other study ID #: BREN01_CLIN_001
• Status: Terminated
• Start date: January 14, 2019
• Est. completion date: April 18, 2021

Study information

• Verified date: December 2022
• Source: BrainEver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 18, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil
France	Hôpital Pitié-Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BrainEver

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline of brain MRI	neuromelanin sequence	12 and 24 months