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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01385592
Other study ID # CAFQ056A2222
Secondary ID 2011-002073-30
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date September 2012

Study information

Verified date March 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)


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Study Design


Intervention

Drug:
AFQ056

Placebo


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Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile 12 weeks
Secondary Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) 12 weeks
Secondary Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) 12 weeks
Secondary Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) 12 weeks
Secondary Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS ) 12 weeks
Secondary Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events 12 weeks
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