Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis|
- The Average Pain Score at target site.
- The Worst Pain Score at target site.
- The Pain at Night Score at target site.
- Quality of Life measures.
- Patient satisfaction with treatment.
- Safety will be assessed through the collection of AEs and vital signs.
|Study Start Date:||September 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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 clinical trial evaluating Cesamet™ treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a Treatment Phase.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381264
|United States, Florida|
|South Florida Medical Research|
|Aventura, Florida, United States, 33180|
|Sunrise Clinical Research, Inc.|
|Hollywood, Florida, United States, 33021|
|Naples Anesthesia and Pain Associates|
|Naples, Florida, United States, 34108|
|Lazlo Mate, MD|
|West Palm Beach, Florida, United States, 33407|
|Principal Investigator:||Joseph V Pergolizzi, MD||NEMA Research, Inc.|
|Study Director:||Charlotte A Richmond, PhD||Nema Research|