Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis - Full Text View

Sponsored by:	NEMA Research, Inc.
Information provided by:	NEMA Research, Inc.
ClinicalTrials.gov Identifier:	NCT00381264

Purpose

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

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Cesamet™ (nabilone)	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Nabilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis

Further study details as provided by NEMA Research, Inc.:

Primary Outcome Measures:

The Average Pain Score at target site.

Secondary Outcome Measures:

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.

Estimated Enrollment:	23
Study Start Date:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381264

Locations

United States, Florida
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
South Florida Medical Research
Aventura, Florida, United States, 33180
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
Lazlo Mate, MD
West Palm Beach, Florida, United States, 33407

Sponsors and Collaborators

NEMA Research, Inc.

Investigators

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

More Information

Additional Information:

Nema Research website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NEMA Research ( Joseph Pergolizzi, MD )
Study ID Numbers:	CB1 Study 002
Study First Received:	September 25, 2006
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00381264
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Multiple sclerosis
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Pain
Nabilone
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Tranquilizing Agents
Immune System Diseases
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics

Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2009