CWoW - Study in MS patient Naïve to treatment with Nabiximols
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Explore the Effect of Nabiximols Oromucosal Spray on Clinical and Pharmacodynamic Measures in Patients with Multiple Sclerosis Who are Naïve to Treatment with Nabiximols for Spasticity
IRAS ID
271438
Contact name
Rachel Farrell
Contact email
Sponsor organisation
GW Pharma Limited
Eudract number
2019-002625-29
Duration of Study in the UK
0 years, 6 months, days
Research summary
Summary of Research
This is a randomised, multi-centre, double-blind, placebo-controlled study in male and female participants aged 18 years and above. This study will explore the effect of Nabiximols (known as Sativex Oromucosal Spray in the UK) oromucosal spray in participants with Multiple Sclerosis who have not been treated with Nabiximols for spasticity, to determine if this is an effective therapy.This study will consist of a screening period to determine eligibility. After which participants will be assigned to either Nabiximols or placebo for up to 21 days (Treatment Period 1). Following Treatment Period 1 participants will not take Nabiximols or placebo during a 7 day period. After this 7 day period, participants who took Nabiximols during Treatment Period 1 will take Placebo for up to 21 days (Treatment Period 2). Those participants that were assigned to placebo during Treatment Period 1 will take Nabiximols during Treatment Period 2. Neither the participant nor the study doctor will know when participants are taking Nabiximols and placebo.
After both treatment periods are complete, participants will have a safety follow-up visit, which will mark the end of the study for the participant.
During the study participants will undergo a number of procedures include blood and urine test, electrocardiograms, questionnaires etc. Participants will also be required to complete an electronic diary daily.
Summary of Results
What was the purpose of the study?The main question the researchers wanted to answer in this trial was:
• Does nabiximols have a greater effect on participant’s leg spasticity compared to placebo?
To answer this question, the researchers evaluated the scores measured by the Modified Ashworth Scale (MAS) which conducts several tests of leg spasticity. These tests produce a score for the Lower Limb Muscle Tone – 6 (LLMT-6). The LLMT-6 can be scored from 0 to 5. A decrease in scores means a decrease in spasticity symptoms.
What were the results of the study?
Out of the 68 participants that took part in the trial, only 66 participants received nabiximols (during the nabiximols treatment period), and only 65 participants received placebo (during the placebo treatment period). Only results of the participants who received both study treatments are included in this summary.
The results of this trial show that nabiximols did not have a greater effect on participant’s leg spasticity as compared to placebo. The difference in LLMT-6 scores was not significant between participants taking nabiximols versus placebo. While taking nabiximols, there was an average decrease of 0.23 points and while taking placebo, there was an average decrease of 0.26 points from the start of each treatment.What medical problems (side effects) did the participants have?
Approximately 4 out of 10 (41%) participants taking nabiximols and 2 out of 10 (23%) participants taking placebo experienced non-serious side effects. All non-serious side effects were mild to moderate. A side effect is considered serious when it is life threatening, causing lasting problems or requires hospital care. 1 participant (2%) taking nabiximols and 1 participant (2%) taking placebo reported serious side effects. No participants died during the clinical trial. All serious side effects were resolved, and none were considered by the investigator to be related to nabiximols.
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 NCT04657666 • Clinicaltrialsregister.eu – Search for 2019-002625-29
This summary was created in April 2023. The information in this summary does not include any information available after this date.
REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0152
Date of REC Opinion
16 Mar 2020
REC opinion
Further Information Favourable Opinion