A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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