Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2022-08-15

Brief Summary

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This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.

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Detailed Description

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Conditions

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Parkinson Disease Dyskinesia, Drug-Induced Dyskinesias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dipraglurant TID

Group Type EXPERIMENTAL

Dipraglurant

Intervention Type DRUG

Oral 50 mg and 100 mg tablet

Interventions

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Dipraglurant

Oral 50 mg and 100 mg tablet

Intervention Type DRUG

Other Intervention Names

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ADX48621

Eligibility Criteria

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Inclusion Criteria

* Completed an Addex randomized controlled study of dipraglurant and, in the judgement of the Investigator, may benefit from open-label treatment
* Able to take study drug 3 times daily and no less than 3 hours apart
* Must be taking levodopa not less than 3 times daily throughout the study
* Must maintain stable regimen of antiparkinson's medications (including levodopa) and be willing to continue the same doses and regimens for the first 4 weeks of the study

Exclusion Criteria

* Patient is judged by the Investigator to be inappropriate for the study (for reasons such as, but not limited to, significant noncompliance in the Addex randomized controlled study of dipraglurant)
* Use of amantadine or amantadine ER throughout the study
* Use of memantine throughout the study
* Any use of marijuana or other cannabis/cannabinoid products for the first 4 weeks of study participation

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No