Status:
COMPLETED
Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Dyskinesias
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
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)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01491529
Start Date
April 1 2012
End Date
April 1 2013
Last Update
December 23 2020
Active Locations (39)
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1
Novartis Investigative Site
Sunnyvale, California, United States, 94089
2
Novartis Investigative Site
Englewood, Colorado, United States, 80113
3
Novartis Investigative Site
Tampa, Florida, United States, 33612
4
Novartis Investigative Site
Kansas City, Kansas, United States, 66160