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Completed

NCT Number: NCT00175955

Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

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

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Key information

Conditions

Dyskinesia, Medication-Induced Central Nervous System Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Dyskinesia, Drug-Induced Dyskinesias Movement Disorders Nervous System Diseases Neurologic Manifestations Neurotoxicity Syndromes Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Antwerp, Belgium

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

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

Secondary outcomes

  1. Neuroleptic-induced akathisia and other extrapyramidal symptoms ,

  2. Effect on the primary psychiatric disorder

  3. Safety

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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