Dyskinesia, Drug-Induced, Levodopa, Parkinson Disease
Conditions
Keywords
Parkinson Disease, L-dopa, Levodopa, Dyskinesia, involuntary movement, motor complication
Brief summary
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).
Interventions
DRUGAFQ056
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.
Exclusion criteria
* Surgical treatment for PD * Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). | 3.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of dyskinetic symptoms by change from baseline in mAIMS total score | 3.5 years |
| Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively | 3.5 years |
Countries
Australia, Canada, France, Germany, Italy, United States
Outcome results
None listed