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Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01474421
First received: October 5, 2011
Last updated: March 27, 2013
Last verified: March 2013
History of Changes

October 5, 2011
March 27, 2013
September 2011
February 2013   (final data collection date for primary outcome measure)
  • Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    Dyskinesia with a maximal score of 24.
  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    Anti-parkinsonian effect in PD patients.
  • Safety and tolerability [ Time Frame: Up to Day 42 ] [ Designated as safety issue: Yes ]
    Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure
Same as current
Complete list of historical versions of study NCT01474421 on ClinicalTrials.gov Archive Site
  • Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) [ Time Frame: Up to Day 42 ] [ Designated as safety issue: No ]
    Assesses the degree to which dyskinesia interferes with five activities of daily living, with a higher score indicating more severe impairment.
  • Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33 [ Time Frame: Up to Day 42 ] [ Designated as safety issue: No ]
    Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week.
  • Track-PD [ Time Frame: Up to Day 42 ] [ Designated as safety issue: No ]
    Objective measures of motor function.
  • CogState [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
    Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function.
  • Area under the curve (AUC[0-24hr]) of AQW051 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias

This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dyskinesia,
  • Drug-induced
  • Drug: AQW051
    Patients will receive AQW051 in a high dose once daily orally for 28 days.
  • Drug: AQW051
    Patients will receive AQW051 in a low dose once daily orally for 28 days.
  • Drug: Placebo
    Patients will receive placebo once daily orally for 28 days.
  • Experimental: AQW051 High Dose
    AQW051 high dose daily given orally for 28 days.
    Intervention: Drug: AQW051
  • Experimental: AQW051 Low Dose
    AQW051 low dose daily given orally for 28 days.
    Intervention: Drug: AQW051
  • Placebo Comparator: Placebo
    Placebo daily given orally for 28 days.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Parkinson's disease
  • Patients with dyskinesias for at least 3 months
  • Patients with moderate to severe dyskinesias
  • Patients on L-dopa treatment for at least 3 years

Exclusion Criteria:

  • Patients with atypical Parkinson's disease
  • Patients who have had prior surgery for Parkinson's disease
  • Patients who are cognitively impaired, have psychosis, have confusional states or hallucinate
  • Patients who received neuroleptics or anti-psychotics within 2 months
  • Women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy
 
NCT01474421
CAQW051A2209, 2011-001092-39
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP