Status:
COMPLETED
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis
Lead Sponsor:
NEMA Research, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to Multiple Sclerosis.
Detailed Description
The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to Multiple Sclerosis. This is a phase IV, multi-center, open label outpatient c...
Eligibility Criteria
Inclusion
- Patients diagnosed with MS
- Chronic daily pain present for at least 2 months.
- On stable analgesic regimen for one month
- Baseline pain score greater than 40mm on a visual analog scale.
Exclusion
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00381264
Start Date
September 1 2006
End Date
October 1 2007
Last Update
February 15 2008
Active Locations (4)
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1
South Florida Medical Research
Aventura, Florida, United States, 33180
2
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
3
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
4
Lazlo Mate, MD
West Palm Beach, Florida, United States, 33407