MS Trial Alert: Investigators Recruiting People with MS for Study of a Plant-Derived Oral Cannabinoid Spray to Treat Muscle Spasticity
July 28, 2022
SUMMARY: Investigators are recruiting 446 people with MS worldwide who are being treated for spasticity for a study testing whether adding nabiximols (an oral spray), to ongoing antispasticity therapy can reduce MS-related muscle spasms. The study is sponsored by Jazz Pharmaceuticals.
: Cannabinoids are the chemical compounds secreted by cannabis flowers. When consumed, cannabinoids bind to docking sites or receptors in the human body and alter nerve transmission in the brain. Nabiximols is a mouth (oromucosal) spray containing two chemical extracts derived from the cannabis
plant: delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Nabiximols is approved to treat MS-related spasticity in countries outside the United States, but has not been approved by the U.S. Food and Drug Administration.
Eligibility and Details
: You may qualify to participate if you are at least 18 years old, were diagnosed with MS more than a year ago, and are on a stable dose of antispasticity therapy (baclofen, tizanidine, or dantrolene) but continue to have daily muscle spasms. Other criteria will be reviewed to determine if you qualify for this study.
Participants who qualify will be randomly assigned to study treatment with either nabiximols or inactive placebo (while continuing to take their antispasticity therapy. These medications will be self-administered by participants as an oral spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks. The primary outcome being measured is change in the number of spasms, and other outcomes include safety and tolerability.
What Else is Involved?
The study involves up to seven in-person visits to the study site. Visits will involve blood draws, clinical exams, and responding to questionnaires.
Please note: This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19.
To learn more about the enrollment criteria for these studies, and to find out if you are eligible to participate, please contact the sites enrolling in the following cities:
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF)
||386-785-2400 Ext 610
|Port Charlotte, FL
|New Orleans, LA
|St. Louis, MO
||215-957-9250 ext 124
|Round Rock, TX
Without participants in research studies, MS research would come to a standstill. Read more here
Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.