NCT00175955

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 6, 2013

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

September 9, 2005

Last Update Submit

December 5, 2013

Conditions

Dyskinesia, Medication-induced

Keywords

Neuroleptic-induced tardive dyskinesiaKeppra, Levetiracetam

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Neuroleptic-induced akathisia and other extrapyramidal symptoms ,

  • Effect on the primary psychiatric disorder

  • Safety

Interventions

LevetiracetamDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Bourgois, Belgium

Location

Unknown Facility

Gonce, Belgium

Location

Unknown Facility

Hulselmans, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Roeselare, Belgium

Location

Unknown Facility

Haralanov, Bulgaria

Location

MeSH Terms

Conditions

Dyskinesia, Drug-Induced

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 6, 2013

Record last verified: 2009-09

Locations

BU(1)BE(6)