Gabapentin for the Treatment of Neuroleptic-Induced Tremor - Full Text View

Sponsor:	Minneapolis Veterans Affairs Medical Center
Collaborator:	Pfizer
Information provided by:	Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00533455

Purpose

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.

Condition	Intervention	Phase
Neuroleptic-Induced Tremor	Drug: Gabapentin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
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.

Resource links provided by NLM:

MedlinePlus related topics: Tremor

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:

Reduction of tremor on the UPDR and SAS
Reduction of instrumental measurements of percent tremor and tremor power.

Secondary Outcome Measures:

Reduction of rigidity, bradykinesia, dyskinesia
Improvement in quality of life

Estimated Enrollment:	40
Study Start Date:	March 2004
Study Completion Date:	August 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533455

Locations

United States, Minnesota
Minneapols VA Medical Center
Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

Minneapolis Veterans Affairs Medical Center

Pfizer

Investigators

Principal Investigator:	Charles E Dean, MD	Minneapols VA Medical Center
Study Director:	Adityanjee Adityanjee, MD	Minneapolis Veterans Affairs Medical Center

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00533455 History of Changes
Other Study ID Numbers:	3232-A
Study First Received:	September 19, 2007
Last Updated:	September 21, 2007
Health Authority:	United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:

Antipsychotics, tremor

Additional relevant MeSH terms:

Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antipsychotic Agents
Gabapentin
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012