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Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00175955
First received: September 9, 2005
Last updated: December 5, 2013
Last verified: September 2009
September 9, 2005
December 5, 2013
May 2005
December 2005   (Final data collection date for primary outcome measure)
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
Same as current
Complete list of historical versions of study NCT00175955 on ClinicalTrials.gov Archive Site
  • Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
  • Effect on the primary psychiatric disorder
  • Safety
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Dyskinesia, Medication-induced
Drug: Levetiracetam
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2005
December 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria
 
 
NCT00175955
N01142
EudraCT Number 2004-001302-27
Not Provided
Not Provided
Not Provided
Not Provided
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP