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.

First Received: December 21, 2007 Last Updated: May 9, 2008 History of Changes

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: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: 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

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAFQ056A2203
Study First Received:	December 21, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00582673 History of Changes
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:

Neurotransmitter Agents
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
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Antiparkinson Agents
Brain Diseases
Neurodegenerative Diseases

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Parkinson Disease
Movement Disorders
Therapeutic Uses
Neurologic Manifestations
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009