Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amantadine; Levodopa

Criteria

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.