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

Sponsors and Collaborators:	1st Hospital of Social Security Services UCB
Information provided by:	1st Hospital of Social Security Services
ClinicalTrials.gov Identifier:	NCT00291733

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 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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial

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
1: Active Comparator 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
2: Placebo Comparator placebo	Drug: Placebo Placebo tabl
3: Active Comparator 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
4: Placebo Comparator 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

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

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

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

Keywords provided by 1st Hospital of Social Security Services:

Levetiracetam
Levodopa-induced dyskinesias
Parkinson's

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

Dopamine
Parkinson Disease
Movement Disorders
Piracetam
Neurologic Manifestations
Etiracetam
Parkinsonian Disorders

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009