Status:
COMPLETED
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Essential Tremor
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Detailed Description
Essential tremor is a very common form of tremor, occurring in up to 5% of people. It may be inherited. In 90% of patients, the tremor is in the hands; however, it can also be in the head, voice, legs...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00236496
Start Date
October 1 2001
End Date
February 1 2004
Last Update
June 10 2011
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