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Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias

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ClinicalTrials.gov Identifier: NCT00160576
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 6, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Drug: Levetiracetam Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : July 2003
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

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Primary Outcome Measures :
  1. 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 :
  1. Reduction in mean duration of dyskinesias per day at 9 month;Safety


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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;

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): NCT00160576


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
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ClinicalTrials.gov Identifier: NCT00160576     History of Changes
Other Study ID Numbers: N01105
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Idiopathic Parkinson's Disease, levodopa induced dyskinesia,
Levetiracetam, Keppra
Additional relevant MeSH terms:
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Levetiracetam
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
Anticonvulsants
Nootropic Agents