Status:
COMPLETED
Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Dyskinesias
Parkinson Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).
Eligibility Criteria
Inclusion
- Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
- Outpatients
- Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements
Exclusion
- Atypical or secondary form of Parkinson's disease
- History of surgical treatment for PD including deep brain stimulation
- Advanced, severe, or unstable disease (other than PD)
- History of malignancy
- Evidence of dementia
- Untreated/ineffectively treated mental disorders
- Treatment with certain prohibited medications
- Abnormal lab values or heart abnormalities
- Pregnant or nursing women
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01491932
Start Date
March 1 2012
End Date
October 1 2013
Last Update
December 23 2020
Active Locations (32)
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1
Novartis Investigative Site
Englewood, Colorado, United States, 80113
2
Novartis Investigative Site
Kansas City, Kansas, United States, 66160
3
Novartis Investigative Site
Milwaukee, Wisconsin, United States, 53233
4
Novartis Investigative Site
Innsbruck, Austria, A-6020