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Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias
This study has been completed.
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00160576
  Purpose

This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the benefit on the motor function of the antiparkinsonian treatment.


Condition Intervention Phase
Idiopathic Parkinson Disease
Drug: Levetiracetam
Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Levetiracetam Levodopa
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease

Further study details as provided by UCB:

Primary Outcome Measures:
  • Evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease by assessing the reduction in mean duration of dyskinesias during "on" period at 10-week

Secondary Outcome Measures:
  • Reduction in mean duration of dyskinesias per day at 9 month;Safety

Estimated Enrollment: 30
Study Start Date: July 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Male / female adult, 30 years old or more;
  2. Subject suffering from Idiopathic Parkinson's Disease, diagnosed according to the UK Brain Bank Criteria (see Appendix 14.8) (1) , since a minimum of 3 years, and stabilized with regard to the motor function (ratio .on./.off. over the day);
  3. Subject treated with levodopa whether or not combined with any other antiparkinsonian drugs (except apomorphine) for minimum one year;
  4. Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:

    1. with a minimum score of 2 on item 33 of the UPDRS-Part IV (moderately disabling dyskinesias);
    2. with a minimum score of 2 on item 32 of the UPDRS-Part IV (dyskinesias present during more than 25% of the waking day).

Exclusion Criteria:

  1. Dyskinesias that cannot reliably be characterized on a regular basis by the subject himself/herself (more than 5 .errors. on DRC per 24 hours after repeated training);
  2. Subject currently treated with apomorphine or neuroleptic drugs either typical or atypical such as clozapine, olanzapine or risperidone;
  3. Subject currently treated with dopamine antagonists such as but not limited to metoclopramide, alizapride or phenothiazine derivatives (e.g. metopimazine). If necessary, the use of the dopamine antagonist domperidone is allowed.
  4. Subject Who had undergone or who was scheduled for functional neurosurgery for Parkinson's disease during the trial period;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160576

Sponsors and Collaborators
UCB
Investigators
Study Director: Françoise Tonner, MD unaffiliated
  More Information

Study ID Numbers: N01105
Study First Received: September 8, 2005
Last Updated: March 7, 2008
ClinicalTrials.gov Identifier: NCT00160576  
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines;   France: Afssaps - French Health Products Safety Agency;   Portugal: National Pharmacy and Medicines Institute

Keywords provided by UCB:
Idiopathic Parkinson's Disease, levodopa induced dyskinesia,
Levetiracetam, Keppra

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
Parkinson Disease
Movement Disorders
Piracetam
Neurologic Manifestations
Etiracetam
Parkinsonian Disorders

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009