Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS
Research type
Research Study
Full title
A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis
IRAS ID
270371
Contact name
Klaus Schmierer
Contact email
Sponsor organisation
GW Pharma Ltd
Eudract number
2019-002623-14
Clinicaltrials.gov Identifier
IND 140706, IND Number
Duration of Study in the UK
2 years, 5 months, 3 days
Research summary
Summary of Research
Multiple sclerosis (MS) is a progressive, chronic, immune-mediated disease of the central nervous system (CNS). The pathological hallmarks of MS include focal inflammation, demyelination, some remyelination, neuro-axonal loss, and gliosis. These processes lead to delay and block of the usually speedy nerve conduction thereby causing disabling symptoms.\n \nMS affects more than 2.3 million people worldwide. \n\nThe condition significantly affects quality of life due to restricted mobility, spasticity, fatigue, sensory deficits, weakness, pain, bladder dysfunction, cognitive dysfunction and visual impairment. Spasticity is one of the most common symptoms of MS, and the quality of life of people with MS decreases as spasticity severity increases. \n\nSpasticity is treated with physiotherapy and anti-spastic medications. However, as the disease progresses the incidence and severity of spasticity increases despite the available treatment options. Nabiximols (GW-1000-02) / Sativex) has been shown to provide symptomatic improvement of moderate to severe spasticity. This study aims to demonstrate the efficacy of nabiximols in the treatment of muscle spasms associated with MS.\n\nNabiximols is an oromucosal spray which is a complex botanical mixture, containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) as the principal cannabinoids as well as non-cannabinoid components. \n\nThis is a double blind, randomised, placebo controlled study. This means neither the study doctor nor the participant will know if they are taking the study medication (Nabiximols) or placebo. The study will include a 28 day baseline, 12 week treatment, and 2 week follow up period. Participants will be asked to complete electronic questionnaires, have physical examinations, blood tests, and functional assessments as well as pharmacokinetic blood testing. \nSummary of Results
GW Pharma sponsored this trial and would like to thank everyone who participated in this study of nabiximols.
Many people with Multiple Sclerosis (MS) experience an abnormal increase in muscle tone or stiff muscles. When the muscles contract, become stiff, or spasm involuntarily, this condition is called spasticity. People with MS experiencing spasticity, who are not achieving enough relief from prescribed anti-spasticity medication, were asked to participate in the trial. The purpose of this trial was to evaluate if adding nabiximols to prescribed anti-spasticity medication would have a greater effect on decreasing the number of daily spasms in participants with MS compared to placebo. Nabiximols is a mouth spray that contains the study medicine. Placebo is also a mouth spray that looks like nabiximols but has no medicine in it.A total of 137 male and female participants aged 46 to 61 years took part in this trial across the USA and 4 countries in Europe between October 2020 and February 2023. 1 of the 137 participants was enrolled in the UK. Each participant was randomly assigned to either be in the nabiximols group, where they received nabiximols for 12 weeks, or in the placebo group, where they received placebo for 12 weeks. The participants, trial doctors, other trial staff, and sponsor did not know what treatment the participant was receiving while on the trial.
Summary of Results
What was the purpose of the study?
The main question the researchers wanted to answer in this trial was:
• Does adding nabiximols to prescribed anti-spasticity medication have a greater effect in decreasing the number of daily spasms compared to placebo?
To answer this question, the researchers asked participants how many spasms they experience in a day, from prior to beginning treatment in the trial to 12 weeks after treatment.What were the results of the study?
The trial was stopped before completion due to an internal company decision. The decision was not because of any safety concerns with nabiximols. As a result, the trial did not enroll the 446 participants originally planned to answer the main question of the researchers. The analysis of the 137 participants enrolled before the trial was stopped showed that participants who received nabiximols, in addition to their anti-spasticity medications, experienced a decrease of 3.84 average daily spasms while participants who received placebo in addition to their anti-spasticity medications experienced a decrease of 3.11 average daily spasms.What medical problems (side effects) did the participants have?
Non-serious side effects were experienced by approximately 7 out of 10 (70%) participants in the nabiximols group and 5 out of 10 (46%) participants in the placebo group. A side effect is considered serious when it is life threatening, causing lasting problems, requires hospital care or prolonging of hospital care, or causes a birth defect. 3 participants (5%) in the nabiximols group and 5 participants (7%) in the placebo group reported serious side effects. All serious side effects were resolved, and none were considered by the investigator to be related to nabiximols. No participants died during the clinical trial.This summary only shows the results of this clinical trial. Other clinical trials may have different results. No other clinical trials with nabiximols are currently ongoing or planned. Additional information can be found on the following websites:
• Clinicaltrials.gov – Search for NCT04203498
• Clinicaltrialsregister.eu – Search for 2019-002623-14This summary was created in January 2024. The information in this summary does not include any information available after this date.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0376
Date of REC Opinion
21 Feb 2020
REC opinion
Further Information Favourable Opinion