A Phase 2 interventional study of Nabilone in Fibromyalgia, sponsored by Winnipeg Regional Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-08-25.
Sponsored by Winnipeg Regional Health Authority · Phase 2, Interventional, and Treatment
Among 42 studies in Fibromyalgia with a site in Canada — 4 open to participants now, 4 under way, none of them phase 3. Fibromyalgia · Canada.
Among the 42 studies in Fibromyalgia with a site in Canada, this one is the 28th largest by enrollment of the 37 interventional ones, is one of 4 that started in 2006, is one of 6 in phase 2, and was the 2nd registered.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →4 of the 42 studies in Fibromyalgia with a site in Canada are open now, in 1 country. Each count lists the studies.
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →42 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2006.
Median enrollment 67 across the 37 interventional studies, 81 across the 5 observational. Of the 36 that completed or were terminated, 8 (22%) have results posted.
13 of 42 have an industry lead sponsor. The 10 most frequent:
Winnipeg Regional Health Authority is the lead sponsor of 2 studies on the registry; none are open to participants now.
Winnipeg Regional Health Authority has 1 study filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
2 of the studies in Fibromyalgia with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03910010Nova Scotia Health AuthorityBrain Imaging Study on Biomarkers for Fibromyalgia | 2027-02 |
| NCT07659873Women's College HospitalAdvancing Online Psychology Tools for Chronic Pain | 2027-10 |
Among the 42 studies in Fibromyalgia with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Fibromyalgia is a disease of unknown cause. People with fibromyalgia experience diffuse body pain, fatigue, sleep disturbance, and a generalized stiffness and swollen feeling. Fibromyalgia affects 2-6% of the general population, affecting females more commonly than males. Symptoms usually start between 20 and 55 years of age.
No medical treatment has been specifically approved for the management of fibromyalgia, however, there is strong evidence that some antidepressants, exercise, and patient education are effective in reducing the pain experienced by fibromyalgia patients. A recent study of four patients has suggested the possible benefit of Nabilone, a synthetic cannabinoid, in the treatment of fibromyalgia, however more studies are needed.
Marijuana is the common name for cannabis. Nabilone (brand name, CESAMET®), is a synthetic cannabinoid (form of cannabis). Cannabinoid receptors exist naturally in the human body and respond to naturally occurring cannabinoids produced by the body, as well as marijuana and synthetic cannabinoids like Nabilone.
In Canada, Nabilone is approved for the treatment and management of severe nausea and vomiting associated with cancer chemotherapy and may be prescribed by physicians.
Research has shown that activating the cannabinoid receptors also has an effect on reducing acute and chronic pain.
Our hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the pain experienced by patients with fibromyalgia and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, number of tender points, average pain threshold, and scores on the Fibromyalgia Impact Questionaire.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At baseline, then again at weeks 2, 4 and 8.
The record gives a start of Apr 2006, a primary completion of Feb 2007 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nabilone
Winnipeg Regional Health Authority