Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT00381264
• Recruitment Status: Completed
• First Posted: September 27, 2006
• Last Update Posted: February 15, 2008
• Sponsor: NEMA Research, Inc.
• Information provided by: NEMA Research, Inc.

Tracking Information

• First Submitted Date: September 25, 2006
• First Posted Date: September 27, 2006
• Last Update Posted Date: February 15, 2008
• Study Start Date: September 2006
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 25, 2006): The Average Pain Score at target site.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 25, 2006)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis
• Official Title: A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis
• 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 clinical trial evaluating Cesamet™ treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a Treatment Phase.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Sclerosis
• Intervention: Drug: Cesamet™ (nabilone)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 25, 2006): 23
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• Hypersensitivity to compounds in study drug or similar drugs
• Pregnant or lactating females
• Drug or alcohol abuse
• Unstable medical condition

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00381264
• Other Study ID Numbers: CB1 Study 002
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joseph Pergolizzi, MD, NEMA Research
• Original Responsible Party: Not Provided
• Current Study Sponsor: NEMA Research, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph V Pergolizzi, MD; NEMA Research, Inc.
• Study Director: Charlotte A Richmond, PhD; Nema Research

• PRS Account: NEMA Research, Inc.
• Verification Date: February 2008