CannTrust is getting ready to launch a clinical trial to assess the effectiveness of its cannabidiol (CBD) oil capsules on slowing the progression of amyotrophic lateral sclerosis (ALS) and otherÂ motor neuron diseases (MNDs).
This new study is the result of a collaboration between Canada-based CannTrust and Gold Coast University Hospital, one of the leading tertiary referral institutions in Australia for ALS management.
â€śThis study will help advance our understanding of the potential effects of CannTrustâ€™s standardized CBD oil capsules on ALS/MND, both as a disease modifying agent and as a symptomatic treatment and will become the basis for conducting future cannabinoid and ALS clinical trials,â€ť Arman Sabet, MD, a neurologist at Gold Coast University Hospital and the lead researcher of the study, said in a press release.
The randomized, double-blind, placebo-controlled study will assign participants to receive either CannTrustâ€™s standardized CBD oil capsules or a placebo for about six months.
Researchers will evaluate the effects of the treatment on disease manifestations including pain, weight loss, and muscle contraction (spasticity), as well as its impact on patientsâ€™ quality of life and the therapyâ€™s potential to prevent motor function decline in patients with ALS and MND. They will also assess the incidence of treatment-related adverse events and its tolerability profile.
The study has received research ethics board approval and Australian Therapeutic Goods Administration acknowledgement for the therapy, which are regulatory requirements that guarantee the safety of the participants.
â€śThe rate of ALS progression is often rapid, creating high levels of disability for patients. People diagnosed with ALS have an average life expectancy of 2.5 years,â€ť said Eric Paul, CEO of CannTrust. â€śCannTrust is proud to participate in this important study which aims to help us better understand the potential impact of CannTrust CBD oil capsules on ALS and MND, so that patients might face better outcomes.â€ť
CBD is one of the more than 100 pharmacologically active compounds (cannabinoids) that can be retrieved from the cannabis plant. Studies have suggested it can modulate spasticity, as well manage seizures, inflammation, pain, anxiety, and other conditions.
Studies have demonstrated that cannabinoids have neuroprotective activity in animal models of ALS, and they can delay disease progression and prolong survival of the animals. Few studies have investigated the effect of cannabinoids in humans, which makes it difficult to fully understand its effects.
Because it does not have the psychoactive properties common to other cannabis-related compounds, CBD holds greater therapeutic potential. Still, it has been linked to some adverse side effects, such as drowsiness, decreased appetite, diarrhea, fatigue, and convulsions.