Levetiracetam in the Treatment of Neuroleptic-Induced Tardive Dyskinesia - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00175955

Purpose

An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia

Condition	Intervention	Phase
Dyskinesia, Medication-Induced	Drug: Levetiracetam	Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	An 8-Week Exploratory, Double-Blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-Induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.

Further study details as provided by UCB:

Primary Outcome Measures:

Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period

Secondary Outcome Measures:

Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
Effect on the primary psychiatric disorder
Safety

Estimated Enrollment:	70
Study Start Date:	May 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Subjects between ages 18 and 80 years
Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening
Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria
Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening

Exclusion Criteria:

Presence of any axis II condition within 6 months prior to screening
Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia
Start of drugs-other than neuroleptics- that can cause dyskinesia
Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175955

Locations

Belgium

Hulselmans, Belgium

Antwerpen, Belgium

Bourgois, Belgium

Roeselare, Belgium

Gonce, Belgium

Liège, Belgium
Bulgaria

Haralanov, Bulgaria

Sponsors and Collaborators

UCB

Investigators

Study Director:

Barbara Bennett, PhD

UCB

More Information

Study ID Numbers:	N01142, EudraCT Number 2004-001302-27
Study First Received:	September 9, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00175955
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Poland: Ministry of Health

Keywords provided by UCB:

Neuroleptic-induced tardive dyskinesia
Keppra, Levetiracetam

Study placed in the following topic categories:

Dyskinesia, Drug-Induced
Neurotoxicity Syndromes
Neurotoxicity syndromes
Poisoning
Central Nervous System Diseases
Disorders of Environmental Origin
Dyskinesia, drug induced
Dyskinesias
Oral facial dyskinesia

Signs and Symptoms
Drug Toxicity
Mental Disorders
Movement Disorders
Piracetam
Neurologic Manifestations
Etiracetam
Tardive dyskinesia

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