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

Multiple Sclerosis Clinical Trial

Official title:

A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381264
• Other study ID #: CB1 Study 002
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2006
• Last updated: February 14, 2008
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2008
• Source: NEMA Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to Multiple Sclerosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Cesamet™ (nabilone)

Locations

Country	Name	City	State
United States	South Florida Medical Research	Aventura	Florida
United States	Sunrise Clinical Research, Inc.	Hollywood	Florida
United States	Naples Anesthesia and Pain Associates	Naples	Florida
United States	Lazlo Mate, MD	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NEMA Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Average Pain Score at target site.
Secondary	The Worst Pain Score at target site.
Secondary	The Pain at Night Score at target site.
Secondary	Quality of Life measures.
Secondary	Patient satisfaction with treatment.
Secondary	Safety will be assessed through the collection of AEs and vital signs.

External Links

•   Nema Research website