A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia

NCT00272207 | Completed Phase 2

• 1 other identifier: WPG2005#1974
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Cannabinoids; Nabilone; Cesamet; Pain

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale Pain Scores

  Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable

  Baseline, then at week 2, 4 and 8

• Number of Tender Points

  Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded

  At baseline, then at the week 2, 4 and 8 visits

• Average Pain Threshold

  Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold

  At baseline, then at the 2, 4 and 8 week visits

• Fibromyalgia Impact Questionaire

  Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.

  At baseline, then again at weeks 2, 4 and 8.

Interventions

Nabilone DRUG

Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.

Also known as: Cesamet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient meets The American College of Rheumatology (1990) criteria for the classification of fibromyalgia. \[5\]
• years old.
• Any gender.
• The patient has not received benefit from a tricyclic antidepressant, muscle relaxant, acetaminophen or non-steroidal anti-inflammatories for management of their pain.
• No previous use of oral cannabinoids for pain management.

You may not qualify if:

• The patient's pain is better explained by a diagnosis other then fibromyalgia.
• Abnormalities on routine baseline blood work including electrolytes, urea and creatinine, a complete blood count, and liver function tests (AST ALT GGT, Alk Phos, and LDH). Normal tests taken within 3 months prior to the study will be accepted if there is no history of acute illness since the time the blood was drawn.
• Heart disease. (Cannabinoids can reduce heart rate and blood pressure) Patients with heart disease will be excluded based on a history of angina, MI or CHF as well as a clinical exam.
• Schizophrenia or other Psychotic disorder
• Severe liver dysfunction. (Patients will be excluded if there is an elevation of any of the baseline liver enzymes)
• History of untreated non-psychotic emotional disorders.
• Cognitive impairment.
• Major illness in another body area.
• Pregnancy.
• Nursing mothers.
• Patients less than 18 years old.
• History of drug dependency.
• A known sensitivity to marijuana or other cannabinoid agents

Sponsors & Collaborators

• Winnipeg Regional Health Authority: lead
• Valeant Canada Limited: collaborator

Study Sites (1)

Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

nabilone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lena Galimova, MD

  The Royal College of Physicians and Surgeons of Canada

  PRINCIPAL INVESTIGATOR

• Ryan Skrabek, MD

  University of Manitoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 4, 2006
• Study Start: April 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2007
• Last Updated: August 25, 2011

Record last verified: 2011-08

Locations

CA (1)