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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00175955

Enrollment

Registered

2005-09-15

Start date

2005-05-31

Completion date

2005-12-31

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyskinesia, Medication-induced

Keywords

Neuroleptic-induced tardive dyskinesia, Keppra, Levetiracetam

Brief summary

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

Interventions

DRUGLevetiracetam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period	—

Secondary

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

Countries

Belgium, Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026