Dyskinesia, Drug-Induced, Dyskinesias, Parkinson Disease
Conditions
Keywords
Parkinson's disease, Dyskinesia, Levodopa-induced Dyskinesia
Brief summary
This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.
Interventions
DRUGDipraglurant
Oral 50mg and 100mg tablet
DRUGPlacebo
Oral matching placebo tablet
Sponsors
Addex Pharma S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily. * Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments. * Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.
Exclusion criteria
* Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation). * Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments. * Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study. * Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening. Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score | Baseline (Day 1) to Week 12 | The UDysRS is a dyskinesia rating scale scored from 0-104 that evaluates involuntary movements associated with PD. A higher score indicates more severe dyskinesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary | Baseline (Day 1) to Week 12 | A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. |
| Change from baseline in OFF time based on a standardized PD diary | Baseline (Day 1) to Week 12 | A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. |
Countries
United States
Outcome results
None listed