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

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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
Overland Park, Kansas 66210
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Aurora, Colorado 80010
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Chicago, Illinois 60637
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Gainesville, Georgia 30501
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Los Angeles, California 90095
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Madison, Wisconsin 53705
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Miami, Florida 33136
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Phoenix, Arizona 85012
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Phoenix, AZ
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