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NCT Number: NCT01474421

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

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.

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Key information

Conditions

Dyskinesias Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Drug-induced Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bron, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AQW051

Drug

Patients will receive AQW051 in a high dose once daily orally for 28 days.

Placebo

Drug

Patients will receive placebo once daily orally for 28 days.

Primary outcomes

  1. Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score

    Time frame: Baseline, Day 28

    Dyskinesia with a maximal score of 24.

  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score

    Time frame: Baseline, Day 28

    Anti-parkinsonian effect in PD patients.

  3. Safety and tolerability

    Time frame: Up to Day 42

    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 outcomes

  1. Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)

    Time frame: Up to Day 42

    Assesses the degree to which dyskinesia interferes with five activities of daily living, with a higher score indicating more severe impairment.

  2. Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33

    Time frame: Up to Day 42

    Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week.

  3. Track-PD

    Time frame: Up to Day 42

    Objective measures of motor function.

  4. CogState

    Time frame: Up to Day 28

    Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function.

  5. Area under the curve (AUC[0-24hr]) of AQW051

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2011
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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