Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01385592
First received: June 28, 2011
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
| Condition | Intervention | Phase |
|---|---|---|
|
Dyskinesias Parkinson Disease Movement Disorders Parkinsonian Disorders |
Drug: AFQ056 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 78 |
| Study Start Date: | November 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AFQ056 100 mg | Drug: AFQ056 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385592
Locations
| United States, California | |
| Novartis Investigative Site | |
| Sunnyvale, California, United States, 94089 | |
| United States, Colorado | |
| Novartis Investigative Site | |
| Englewood, Colorado, United States, 80113 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| London, Ontario, Canada, N6A 4G5 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Gatineau, Quebec, Canada, J9J 0A5 | |
| France | |
| Novartis Investigative Site | |
| Clermont-Ferrand Cedex 1, France, 63003 | |
| Novartis Investigative Site | |
| Lille Cedex, France, 59037 | |
| Novartis Investigative Site | |
| Pessac, France, 33604 | |
| Novartis Investigative Site | |
| Poitiers, France, 86021 | |
| Germany | |
| Novartis Investigative Site | |
| Beelitz-Heilstaetten, Germany, 14547 | |
| Novartis Investigative Site | |
| Berlin, Germany, 12163 | |
| Novartis Investigative Site | |
| Bochum, Germany, 44791 | |
| Novartis Investigative Site | |
| Duesseldorf, Germany, 40225 | |
| Novartis Investigative Site | |
| Kassel, Germany, 34128 | |
| Novartis Investigative Site | |
| Leipzig, Germany, 04103 | |
| Novartis Investigative Site | |
| Muenchen, Germany, 80804 | |
| Novartis Investigative Site | |
| München, Germany, 81675 | |
| Novartis Investigative Site | |
| Stadtroda, Germany, 07646 | |
| Novartis Investigative Site | |
| Westerstede/Oldenburg, Germany, 26655 | |
| Hungary | |
| Novartis Investigative Site | |
| Budapest, Hungary, 1085 | |
| Novartis Investigative Site | |
| Kaposvár, Hungary, 7400 | |
| Novartis Investigative Site | |
| Szeged, Hungary, H-6725 | |
| Italy | |
| Novartis Investigative Site | |
| Bolzano, BZ, Italy, 39100 | |
| Novartis Investigative Site | |
| Pisa, PI, Italy, 56126 | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00163 | |
| Spain | |
| Novartis Investigative Site | |
| Sant Cugat, Barcelona, Spain, 08190 | |
| Novartis Investigative Site | |
| Barcelona, Cataluña, Spain, 08036 | |
| Novartis Investigative Site | |
| Madrid, Spain, 28006 | |
| Novartis Investigative Site | |
| San Sebastian, Spain, 20014 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01385592 History of Changes |
| Other Study ID Numbers: | CAFQ056A2222, 2011-002073-30 |
| Study First Received: | June 28, 2011 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Ministry of Health France: Ministry of Health Italy: Ministry of Health Hungary: National Institute of Pharmacy Spain: Ministry of Health |
Keywords provided by Novartis:
|
Parkinson Disease L-dopa Levodopa Dyskinesia Anti-Dyskinesia Agents |
Additional relevant MeSH terms:
|
Dyskinesias Movement Disorders Parkinson Disease Parkinsonian Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
Levodopa Anti-Dyskinesia Agents Antiparkinson Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013