A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sc
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
IRAS ID
1003523
Eudract number
2020-003271-18
Research summary
Nabiximols (Sativex) in the form of oromucosal spray has already been approved for symptom improvement in patients with
moderate to severe stiffness of the muscles (spasticity) due to multiple sclerosis and whose symptoms have not improved
enough on other oral antispasticity medication. Nabiximols are a complex botanical medicine formulated from extracts of the
cannabis plant that contains the principal cannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains
minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols and
triglycerides.
Participants currently on an antispasticity medication regimen will be asked to continue to take their current therapy – without any
changes - for the duration of the study. If they are currently not on any antispasticity medications, they will be asked to remain off
any such medications for the remainder of the study.
The study will consist of two treatment periods, where participants will receive either nabiximols or a placebo for 21 days per
treatment period (3 consecutive weeks) in an order determined by chance. Participants may receive a placebo which looks like
nabiximols, but contains no medication and is not expected to have any effect. This will allow the sponsor to see if nabiximols
work as well as or better than the placebo.
In either treatment period, participants will have a 50% chance of receiving nabiximols and a 50% chance of receiving the
placebo. Participants will receive a different treatment in each treatment period. There will be a break of 7 days between
treatment periods so that the study medicine is cleared from the body (so called ‘washout period’) before starting the new
treatment. Throughout both treatment periods participants will initiate nabiximols oromucosal spray treatment as a single spray in
the clinic in the morning of Visits 2 (Day 1) and 6 (Day 31) of each treatment period.
The Primary endpoint will be measured with the Change in Lower Limb Muscle Tone-6 (LLMT-6; defined as the average of the 6
individual MAS transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body) from Day 1
pre-dose to Day 21 and from Day 31 pre-dose to Day 51REC name
North East - York Research Ethics Committee
REC reference
21/NE/0027
Date of REC Opinion
18 Feb 2021
REC opinion
Further Information Favourable Opinion