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Gabapentin for the Treatment of Neuroleptic-Induced Tremor

This study has been terminated.
(Failure to recruit due to polypharmacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533455
First Posted: September 21, 2007
Last Update Posted: September 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Minneapolis Veterans Affairs Medical Center
September 19, 2007
September 21, 2007
September 24, 2007
March 2004
Not Provided
  • Reduction of tremor on the UPDR and SAS
  • Reduction of instrumental measurements of percent tremor and tremor power.
Same as current
Complete list of historical versions of study NCT00533455 on ClinicalTrials.gov Archive Site
  • Reduction of rigidity, bradykinesia, dyskinesia
  • Improvement in quality of life
Same as current
Not Provided
Not Provided
 
Gabapentin for the Treatment of Neuroleptic-Induced Tremor
A 4 Week, Parallel-Design, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Treatment of Neuroleptic-Induced Tremor: Clinical and Instrumental Ratings of Outcome.
We will attempt to establish whether gabapentin as compared with placebo will reduce the severity of tremors caused by the use of antipsychotic medications. Baseline severity of tremor will be measured using both clinical ratings and ratings obtained with an instrument designed to measure tremor, giving more objective evidence of tremor frequency and severity.
We propose to enroll 40 veterans with antipsychotic induced tremor in this RCT of gabapentin. Baseline measurements will be obtained with the tremor section of the UPDRS, the Simpson-Angus Scale, the ESRS, AIMS, and the Barnes Akathisia SScale. The Tremorometer, an instrument designed to quantatatively measure frequency, amplitude, and tremor power will be used for baseline and subsequent assessments. Demographic data will be collected. Diagnoses will be established with the SCID. Appropriate lab studies with an EKG will be done at baseline and at study end. Patients will be randomized to gabapentin or placebo and assessed on a blinded basis. Effectiveness of the blind will be assessed at study end. Gabapentin will be started at 300 mg/day and tapered up to a maximum of 1800 mg/day. The SF36 will be used to assess quality of life.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Neuroleptic-Induced Tremor
Drug: Gabapentin
Not Provided
Onofrj M, Thomas A, Paci C, D'Andreamatteo G. Gabapentin in orthostatic tremor: results of a double-blind crossover with placebo in four patients. Neurology. 1998 Sep;51(3):880-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
August 2007
Not Provided

Inclusion Criteria:

  • Veterans 18 and older with an observable tremor judged to be caused by exposure to antipsychotics

Exclusion Criteria:

  • Concomitant use of other anticonvulsants, L-Dopa, cocaine, amphetamines, or other tremorogenic agents excepting SSRIs, TCAs.
  • Current suicidality, severe psychosis, inability to sign informed consent or to cooperate with study procedures.
  • Current use of gabapentin or exposure to gabapentin in the past 2 years.
  • Women who are pregnant, or not using adequate birth control.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00533455
3232-A
No
Not Provided
Not Provided
Not Provided
Minneapolis Veterans Affairs Medical Center
Pfizer
Principal Investigator: Charles E Dean, MD Minneapols VA Medical Center
Study Director: Adityanjee Adityanjee, MD Minneapolis Veterans Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
September 2007

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