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

This study has been completed.
Sponsor:
Information provided by:
NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT00381264
First received: September 25, 2006
Last updated: February 14, 2008
Last verified: February 2008
  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 4

Study Type: Interventional
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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:
No publications provided

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Nabilone
Anti-Anxiety Agents
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014