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

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ClinicalTrials.gov Identifier: NCT00888004
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease L-dopa Induced Dyskinesia Drug: AFQ056 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias
Study Start Date : March 2009
Actual Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Drug: AFQ056
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. Safety and tolerability of administration of AFQ056 in combination with L-dopa [ Time Frame: 20 days ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888004


Locations
Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Kassel, Germany
Novartis Investigative Site
Leun-Biskirchen, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Tubingen, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00888004     History of Changes
Other Study ID Numbers: CAFQ056A2206
2008-006270-15
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs