Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | April 2012 |
End Date: | April 2013 |
Contact: | Novartis Pharmaceuticals |
Phone: | +1(862)778-8300 |
13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
This study will assess the efficacy and safety of modified release AFQ056 in patients that
have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
Inclusion Criteria:
- Males and Females 30-80 years old
- Use of highly effective methods of contraception during study in women of
childbearing potential
- Outpatients
- Clinical diagnosis of Parkinson's Disease according to UK Parkinson's Disease Society
Brain Bank Clinical Diagnosis criteria
- Score of >/= 2 on UPDRS items 32 and 33
- Dyskinesias for at least 3 months before baseline
- On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4
weeks prior to baseline
- Demonstrate capacity to complete accurate diary ratings
- Patients who have a primary caregiver willing to assess the condition of the patient
throughout the study in accordance with protocol requirements
- Group 2 only: Patients must be on a stable and well tolerated dose of amantadine for
at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during
the remainder of the study
Exclusion Criteria:
- Atypical/secondary form of Parkinson's disease
- History of surgical treatment of PD, including deep brain stimulation
- A score of 5 in the "ON"- state on the Modified Hoehn and Yahr scale
- Advanced, severe, or unstable disease other than PD
- Evidence of dementia
- Treatment with certain prohibited medications
- Amantadine within 2 weeks prior to BL1 visit (applies to Group 1 only)
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
9
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials