Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

Dyskinesia, Medication-induced Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175955
• Other study ID #: N01142
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 5, 2013
• Start date: May 2005
• Est. completion date: December 2005

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBulgaria: Bulgarian Drug AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesia, Medication-induced
• Dyskinesias

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Belgium,  Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
Secondary	Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
Secondary	Effect on the primary psychiatric disorder
Secondary	Safety

External Links

•   Clinical Study Summary on UCB.com