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Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by 1st Hospital of Social Security Services.
Recruitment status was:  Active, not recruiting
UCB Pharma
Information provided by:
1st Hospital of Social Security Services Identifier:
First received: February 14, 2006
Last updated: November 14, 2007
Last verified: November 2007

Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.

Study objectives :

  • To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).
  • To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.

Condition Intervention Phase
Levodopa Induced Dyskinesia Drug: Levetiracetam Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial

Resource links provided by NLM:

Further study details as provided by 1st Hospital of Social Security Services:

Primary Outcome Measures:
  • Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Percent change of "on without dyskinesias" and "off" time from patient diaries. Changes in severity and duration of LID according to the UPDRS , Schwab & England scale and also Goetz dyskinesia scale after a levodopa challenge dose. [ Time Frame: 24 hours ]

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Study Completion Date: October 2007
Arms Assigned Interventions
Active Comparator: 1
500mg levetiracetam for one week and 1000mg levetiracetam for one week
Drug: Levetiracetam
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
Placebo Comparator: 2
Drug: Placebo
Placebo tabl
Active Comparator: 3
After crossover arm 3 equals arm 1
Drug: Levetiracetam
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
Placebo Comparator: 4
After crossover arm 4 equals arm 2
Drug: Placebo
Placebo tabl


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.

Other inclusion criteria:

  • Patients between ages 30 and 80
  • Hoehn and Yahr stage of PD over IIb
  • Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication
  • LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV
  • Patient is willing to adhere to protocol requirements as evidence by written informed consent

Exclusion Criteria:

  • Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk.
  • Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal.
  • Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia.
  • Patient has a low Mini-mental Examination MMSE score <25 or has a history of bipolar psychosis or schizophrenia.
  • Patient is unwilling to sign an informed consent or to comply with protocol requirements.
  • Patient is taking or has taken in the past month amantadine.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00291733

Department of Neurology, 1st Hospital of Social Security Services
Athens, Greece, 151-27
Sponsors and Collaborators
1st Hospital of Social Security Services
UCB Pharma
Study Chair: Pantelis Stathis, MD 1st Hospital of Social Security Services
Principal Investigator: Spiros Konitsiotis, MD Department of Neurology, University of Ioannina
Principal Investigator: Vasilis Kyriakakis, MD Department of Neurology, General Hospital of Lamia
Principal Investigator: Georgios Tagaris, MD Department of Neurology, PGNA "Georgios Genimatas"
Principal Investigator: Kostas Papadopoulos, MD Department of Neurology, Hospital of Mental Diseases of Tripolis
  More Information Identifier: NCT00291733     History of Changes
Other Study ID Numbers: VALID-PD
Study First Received: February 14, 2006
Last Updated: November 14, 2007

Keywords provided by 1st Hospital of Social Security Services:
Levodopa-induced dyskinesias

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nootropic Agents
Neuroprotective Agents
Protective Agents processed this record on August 18, 2017