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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
  Purpose

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.


Condition Intervention Phase
Dyskinesia,
Drug-induced
 Drug: AQW051
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AQW051 High Dose
AQW051 high dose daily given orally for 28 days.
 Drug: AQW051
Patients will receive AQW051 in a high dose once daily orally for 28 days.
Experimental: AQW051 Low Dose
AQW051 low dose daily given orally for 28 days.
 Drug: AQW051
Patients will receive AQW051 in a low dose once daily orally for 28 days.
Placebo Comparator: Placebo
Placebo daily given orally for 28 days.
 Drug: Placebo
Patients will receive placebo once daily orally for 28 days.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474421

Locations
United States, California
Novartis Investigative Site
Sacramento, California, United States, 95817
United States, New York
Novartis Investigative Site
Manhasset, New York, United States, 11030
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45219
Novartis Investigative Site
Cleveland, Ohio, United States, 44195
France
Novartis Investigative Site
Bron, France, 69677
Novartis Investigative Site
Clermont Fd, France, 63003
Novartis Investigative Site
Lille Cedex, France, 59037
Novartis Investigative Site
Marseille cedex 05, France, 13385
Novartis Investigative Site
Montpellier cedex 5, France, 34295
Novartis Investigative Site
Nantes Cedex 1, France, 44093
Novartis Investigative Site
Paris, France, 75013
Novartis Investigative Site
Pessac, France, 33604
Novartis Investigative Site
Poitiers, France, 86021
Novartis Investigative Site
Strasbourg, France, 67098
Novartis Investigative Site
Toulouse cedex 9, France, 31059
Germany
Novartis Investigative Site
Berlin, Germany, 10178
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Gera, Germany, 07551
Novartis Investigative Site
Haag, Germany, 83527
Novartis Investigative Site
Kassel, Germany, 34128
Novartis Investigative Site
Marburg, Germany, 35039
Novartis Investigative Site
Muenchen, Germany, 80804
Novartis Investigative Site
Tübingen, Germany, 72076
Italy
Novartis Investigative Site
Roma, RM, Italy, 00163
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: NCT01474421     History of Changes
Other Study ID Numbers: CAQW051A2209, 2011-001092-39
Study First Received: October 5, 2011
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Parkinson's disease
Dyskinesia
Movement disorders
L-dopa

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
 Levodopa
Antiparkinson Agents
Anti-Dyskinesia 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 May 16, 2013