Clinical trial NCT05116813: Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
Official title: An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Dyskinesia, Drug-Induced
Dyskinesias
Keywords: Parkinson's disease
Dyskinesia
Levodopa-induced Dyskinesia
Lead sponsor: Addex Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events
timeFrame: Baseline (Day 1) to Week 52
Secondary outcomes:
measure: Evaluate the continued utility of dipraglurant on dyskinesia as assessed by a change-from-baseline score on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
timeFrame: Baseline (Day 1) to Week 52
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Brunswick
country: United States
facility: Rutgers, the State University of New Jersey
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Abington
country: United States
facility: Abington Neurologic Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: