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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by 1st Hospital of Social Security Services.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
1st Hospital of Social Security Services
ClinicalTrials.gov Identifier:
NCT00291733
First received: February 14, 2006
Last updated: November 14, 2007
Last verified: November 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
placebo
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291733

Locations
Greece
Department of Neurology, 1st Hospital of Social Security Services
Athens, Greece, 151-27
Sponsors and Collaborators
1st Hospital of Social Security Services
UCB Pharma
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00291733     History of Changes
Other Study ID Numbers: VALID-PD
Study First Received: February 14, 2006
Last Updated: November 14, 2007
Health Authority: Greece: National Organization of Medicines

Keywords provided by 1st Hospital of Social Security Services:
Levetiracetam
Levodopa-induced dyskinesias
Parkinson's

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

ClinicalTrials.gov processed this record on October 21, 2014