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Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: September 9, 2005
Last updated: December 5, 2013
Last verified: September 2009
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

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)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00175955

Antwerpen, Belgium
Bourgois, Belgium
Gonce, Belgium
Hulselmans, Belgium
Liège, Belgium
Roeselare, Belgium
Haralanov, Bulgaria
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information: Identifier: NCT00175955     History of Changes
Other Study ID Numbers: N01142
EudraCT Number 2004-001302-27
Study First Received: September 9, 2005
Last Updated: December 5, 2013

Keywords provided by UCB Pharma:
Neuroleptic-induced tardive dyskinesia
Keppra, Levetiracetam

Additional relevant MeSH terms:
Movement Disorders
Dyskinesia, Drug-Induced
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antipsychotic Agents
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on September 21, 2017