Dyskinesia, Drug-Induced, Dyskinesias, Parkinson Disease
Conditions
Keywords
Parkinson's disease, Dyskinesia, Levodopa-induced Dyskinesia
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.
Interventions
DRUGDipraglurant
Oral 50 mg and 100 mg tablet
Sponsors
Addex Pharma S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events | Baseline (Day 1) to Week 52 | Testing the safety and tolerability of dipraglurant in patients with Parkinson's Disease Levodopa-induced dyskinesia based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Baseline (Day 1) to Week 52 | The MDS-UPDRS is a Parkinson's Disease (PD) rating scale scored from 0-272; it evaluates progression of disease in patients with PD. A higher score indicates more severe PD. |
Countries
United States
Outcome results
None listed