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

Addex Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias

Treatments: Drug: Dipraglurant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05116813

ADX48621-302

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Dipraglurant TID

Experimental group

Treatment:

Drug: Dipraglurant