Gabapentin for the Treatment of Neuroleptic-Induced Tremor

Neuroleptic-Induced Tremor Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00533455
• Other study ID #: 3232-A
• Status: Terminated
• Phase: Phase 3
• First received: September 19, 2007
• Last updated: September 21, 2007
• Start date: March 2004
• Est. completion date: August 2007

Study information

• Verified date: September 2007
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Neuroleptic-Induced Tremor
• Tremor

Intervention

Drug:
• Gabapentin

Locations

Country	Name	City	State
United States	Minneapols VA Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of tremor on the UPDR and SAS
Primary	Reduction of instrumental measurements of percent tremor and tremor power.
Secondary	Reduction of rigidity, bradykinesia, dyskinesia
Secondary	Improvement in quality of life