Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

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.

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

Study Overview

• Status: Completed
• Conditions: Dyskinesia, Medication-induced
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment: 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
  • Bourgois, Belgium
  • Gonce, Belgium
  • Hulselmans, Belgium
  • Liège, Belgium
  • Roeselare, Belgium
• Bulgaria
  • Haralanov, Bulgaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Neuroleptic-induced tardive dyskinesia; Keppra, Levetiracetam
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Drug-Related Side Effects and Adverse Reactions; Poisoning; Neurotoxicity Syndromes; Dyskinesias; Tardive Dyskinesia; Dyskinesia, Drug-Induced; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01142; EudraCT Number 2004-001302-27