“Cannabis-derived products are being, or were, evaluated for their potential in treating ALS in various clinical trials.
Sativex (nabiximols), being developed by GW Pharmaceuticals, is an oral spray containing the two active components of cannabis. A Phase 2 trial (NCT01776970) in Italy, called CANALS, evaluated the safety, efficacy, and tolerability of Sativex in ALS patients affected by spasticity, or muscle stiffness. A total of 59 patients, ages 18 to 80, were included in the study. Patients were randomly assigned to receive either Sativex (29 patients) or placebo (30 patients). The study’s findings showed that Sativex was well-tolerated with no serious side effects. Spasticity was significantly reduced in treated patients compared to those given the placebo, whose symptoms continued to worsen.
An earlier single-site study (NCT00812851) tested the efficacy of oral THC in alleviating cramps in ALS patients. This was a crossover study, meaning that all 27 patients enrolled, (mean age 57; with moderate to severe cramps) were given THC at some point during the trial. They were randomly divided into two groups, one receiving 5 mg THC twice daily for two weeks, followed by a placebo; and the other receiving placebo first followed by THC for two weeks. A two-week treatment-free, or washout, period preceded changes in treatment status, and patients were evaluated two weeks after their treatment period.
This trial’s primary goal was changes in cramp intensity. The number of cramps per day, the intensity of muscle twitches, change in appetite, depression, and patient’s quality of life and sleep were measured as secondary goals. Study findings failed to show effectiveness in these measures; THC at 5 mg did did not alleviate cramps in ALS patients, and no significant changes were observed in the secondary outcomes, its researchers reported.
An ongoing Phase 3 study (NCT03690791) is testing the effects of CBD oil capsules by CannTrust on slowing disease progression in ALS patients. The study aims to enroll 30 patients, ages 25 to 75, who will be randomly grouped to receive either the CBD oil capsules or a placebo. In this six-month study, changes in a patient’s motor abilities, lung function, pain and spasticity levels, and quality of life will be assessed to evaluate the efficacy of CBD capsules. Enrollment at this trial’s single site, the Gold Coast Hospital and Health Service in Australia, may still be underway; contact information is available here.
In an observational study (NCT03886753), researchers at Children’s Hospital of Philadelphia are evaluating the effects of four formulations of cannabis-based products — the medical marijuana products Dream, Soothe, Shine, and Ease — by Ilera Healthcare used as standard therapy by people with multiple diseases, including ALS. How this therapeutic moves within the body (its pharmacokinetics) and its chemical interaction in the body (pharmacodynamics) will be monitored, and reports of relief of symptoms collected. The study is enrolling patients, ages 2 and older.
Another large and observational study (NCT03944447) in people with multiple diseases, including ALS, aim to assess the safety and efficacy of cannabis use by up to 10,000 people in the more than 38 states that have legalized medical marijuana. As an observational study, medical cannabis as part of person’s standard therapy — regular use — is being evaluated through patient reporting of perceived relief and findings of side effects.”