Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00175955
First received: September 9, 2005
Last updated: December 5, 2013
Last verified: September 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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, Inc.:

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
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: NCT00175955

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

Additional Information:
No publications provided

ClinicalTrials.gov 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
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
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, Inc.:
Neuroleptic-induced tardive dyskinesia
Keppra, Levetiracetam

Additional relevant MeSH terms:
Dyskinesias
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug Toxicity
Poisoning
Substance-Related Disorders
Antipsychotic Agents
Etiracetam
Piracetam
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014