NCT00236496

Brief Summary

The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo in treating patients with tremor of unknown cause.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2001

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

June 8, 2011

Conditions

Essential Tremor

Keywords

tremoressential tremor

Outcome Measures

Primary Outcomes (1)

  • Clinical Rating Scale for Tremor (TRS) score at Visit 8 (or patient's final visit) of the double-blind phase

Secondary Outcomes (1)

  • TRS subscale scores; composite normalized score; overall TRS score; patient and investigator assessment scores.

Interventions

topiramateDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current symptoms of essential tremor based on the Tremor Investigational Group (TRIG) criteria
  • Dominant upper extremity posture or action intention tremor of 2 (moderate) to 4 (severe)
  • In good health otherwise

You may not qualify if:

  • Patients with abnormal neurologic signs other than essential tremor
  • Taking more than one anti-tremor medication
  • Taking drugs known to cause tremors
  • With physical damage to the nervous system or Parkinson's disease
  • Known to be abusing drugs or alcohol
  • Women who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Essential TremorTremor

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

October 1, 2001

Study Completion

February 1, 2004

Last Updated

June 10, 2011

Record last verified: 2010-04