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Completed

NCT Number: NCT00582673

Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias 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 Investigator Site, Dresden, Germany

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 L-dopa induced dyskinesia for at least 3 months
  • Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion criteria

  • History of severe allergy to food or drugs
  • Very low or high body weight.
  • Prior surgery for Parkinson's Disease
  • Smokers

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

AFQ056

Drug

Placebo

Drug

Primary outcomes

  1. Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa

    Time frame: throughout the study

Secondary outcomes

  1. Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa

Important dates

Study start
2007
Primary completion
2008
First posted
Dec 28, 2007
Registry last updated
May 14, 2010

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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