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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01385592 |
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Date of registration:
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28/06/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
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Scientific title:
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12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01385592 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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France
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Germany
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Hungary
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Italy
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Spain
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing
dyskinesias for at least three months
- Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four
weeks
Exclusion Criteria:
- Surgical treatment for PD
- Cancer within the past 5 years (other than localized skin cancer and prostate cancer
that has been effectively treated)
- Advanced, severe or unstable disease (other than PD) or evidence of dementia that may
interfere with the study outcome evaluations
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinsonian Disorders
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Dyskinesias
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Parkinson Disease
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Movement Disorders
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Intervention(s)
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Drug: Placebo
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Drug: AFQ056
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Primary Outcome(s)
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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
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
[Time Frame: 12 weeks]
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Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )
[Time Frame: 12 weeks]
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Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events
[Time Frame: 12 weeks]
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Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)
[Time Frame: 12 weeks]
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Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)
[Time Frame: 12 weeks]
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Secondary ID(s)
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2011-002073-30
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CAFQ056A2222
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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