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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 is ongoing, but not recruiting participants.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00582673
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: AFQ056
Drug: Placebo
Phase II

Genetics Home Reference related topics:   Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease   

ChemIDplus related topics:   Levodopa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: throughout the study ]

Estimated Enrollment:   34
Study Start Date:   October 2007
Estimated Study Completion Date:   April 2008
Estimated Primary Completion Date:   April 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: AFQ056
2: Placebo Comparator Drug: Placebo

  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 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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582673

Locations
Germany
Novartis Investigator Site    
      Tuebingen, Germany

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     Novartis     Novartis investigative site    
  More Information

Responsible Party:   Novartis ( External Affairs )
Study ID Numbers:   CAFQ056A2203
First Received:   December 21, 2007
Last Updated:   May 9, 2008
ClinicalTrials.gov Identifier:   NCT00582673
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Parkinson's, L-dopa, dyskinesia  

Study placed in the following topic categories:
Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Signs and Symptoms
Dopamine
Parkinson Disease
Movement Disorders
Neurologic Manifestations
Dihydroxyphenylalanine
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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