NCT00533455

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

September 19, 2007

Last Update Submit

September 21, 2007

Conditions

Neuroleptic-Induced Tremor

Keywords

Antipsychotics, tremor

Outcome Measures

Primary Outcomes (2)

  • Reduction of tremor on the UPDR and SAS

  • Reduction of instrumental measurements of percent tremor and tremor power.

Secondary Outcomes (2)

  • Reduction of rigidity, bradykinesia, dyskinesia

  • Improvement in quality of life

Interventions

GabapentinDRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapols VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related 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. doi: 10.1212/wnl.51.3.880.

    PMID: 9748048BACKGROUND

MeSH Terms

Conditions

Tremor

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Charles E Dean, MD

    Minneapols VA Medical Center

    PRINCIPAL INVESTIGATOR

  • Adityanjee Adityanjee, MD

    Minneapolis Veterans Affairs Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

March 1, 2004

Study Completion

August 1, 2007

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

US(1)