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Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

NCT ID: NCT00175955

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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Conditions

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Dyskinesia, Medication-induced

Keywords

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Neuroleptic-induced tardive dyskinesia Keppra, Levetiracetam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Levetiracetam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Antwerp, , Belgium

Site Status

Bourgois, , Belgium

Site Status

Gonce, , Belgium

Site Status

Hulselmans, , Belgium

Site Status

Liège, , Belgium

Site Status

Roeselare, , Belgium

Site Status

Haralanov, , Bulgaria

Site Status

Countries

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Belgium Bulgaria

Other Identifiers

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EudraCT Number 2004-001302-27

Identifier Type: -

Identifier Source: secondary_id

N01142

Identifier Type: -

Identifier Source: org_study_id