The study, “Real world experience of patients with amyotrophic lateral sclerosis (ALS) in the treatment of spasticity using tetrahydrocannabinol:cannabidiol (THC:CBD),” was published recently in the journal BMC Neurology.
Spasticity is a frequent symptom of ALS, manifesting as progressive and often-painful muscle stiffness and involuntary muscle spasms, which can cause discomfort and cramping.
Despite the existence of first-line anti-spastic medications, reducing spasticity in ALS patients remains a main challenge due to the medications’ limited effectiveness and tolerability.
Sativex, developed and commercialized by GW Pharmaceuticals, consists of an oromucosal (mouth) spray that combines two of the most common types of cannabinoids — tetrahydrocannabinol (THC) and cannabidiol (CBD).
Sativex is an approved add-on therapy in the European Union and other countries to treat symptoms of spasticity resistant to first-line anti-spastic treatments in people with multiple sclerosis, a motor neuron disease. In those countries, Sativex has been used as a complementary off-label treatment option for ALS-related spasticity.
Results of a small Phase 2 study, called CANALS trial (NCT01776970), showed Sativex was safe and effective in reducing spasticity in ALS patients. However, no further structured studies evaluating Sativex use and its therapeutic effects in these patients have been reported.
Researchers in Germany evaluated the real-world experience of 44 ALS patients using Sativex to control symptoms of spasticity. Participants were being treated in a tertiary (speciality) ALS center in Berlin, Germany.
The team assessed patients’ spasticity severity through a neurologist’s classification, and the 0–10 spasticity Numerical Rating Scale (NRS), a validated self-reported measure of perceived severity of spasticity.
Patients’ attitude toward Sativex treatment was assessed through the Net Promotor Score (NPS), based on their responses to the question “How likely is it that you would recommend Sativex to a friend or colleague who suffers from ALS and spasticity?”
Sativex treatment satisfaction was measured using the Treatment Satisfaction Questionnaire For Medication (TSQM-9), which includes three main domains: effectiveness, convenience, and global satisfaction.
Patients’ average age was 57.3 years (ranging from 27 to 87 years), and 25 of them (56.8%) were women. Their mean disease duration was 58.4 months. Ten patients (25%) were receiving other anti-spasmic medications in combination with Sativex.
Data was collected through online assessment (18 patients) or a telephone survey (26 patients), and 32 patients had complete data for perceived spasticity, attitude toward Sativex, and satisfaction with Sativex.
Most patients (95.5%) had spasticity in the lower extremities (frequently severe) and more than half (68.2%) showed arm spasticity (frequently mild in severity). The majority of patients (60% to 77%) perceived their spasticity as moderate or severe, 70% reported pain, and and 84% reported muscle cramps.
Patients’ mean Sativex dose was six times daily, ranging from less than one to 20 per day, emphasizing that Sativex was used based on individual patients’ needs and preferences. There was an overall moderately positive recommendation of Sativex among patients, and they were highly satisfied with treatment.
One third of the patients reported reduced satisfaction in the usability of Sativex, which the researchers noted may reflect barriers in handling the mouth spray due to upper body weakness or difficulties in fully opening the mouth.
The team found an association between spasticity severity, Sativex dose, and Sativex recommendation. Patients with moderate-to-severe lower limb spasticity used Sativex more often and were more likely to recommended Sativex to fellow patients than those with mild spasticity.
In total, 40% of the patients discontinued Sativex treatment within the observation period. Since the study’s scope did not include the assessment of reasons behind treatment cessation, “a systematic analysis of [Sativex’s] adverse events and side effects is warranted in order to determine [its] benefit-risk profile … in the treatment of ALS-related spasticity,” the researchers wrote.
They also highlighted that future studies are required not only to confirm these results, but also to define the minimum effective dose of Sativex and compare the effects of Sativex with other anti-spasmic medications in ALS-related spasticity.