Study in MS patients to Evaluate the Effect of a Single Dose of Nabiximols
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of a Single Dose of Nabiximols Oromucosal Spray on Muscle Tone in Patients With Spasticity Associated With Multiple Sclerosis
IRAS ID
1003484
Contact name
Rachel Farrell
Contact email
Eudract number
2019-002624-33
Research summary
This is a multicenter, randomized, placebo-controlled, Phase 1b crossover trial. It is being conducted to evaluate the effect of a single dose of
nabiximols on clinical measures of spasticity in the symptomatic treatment of patients with MS who have achieved some relief from spasticity with
the prescribed use of nabiximols (also known as Sativex®), in combination with other antispasticity medications. The study medicine contains
extracts of cannabis plants: approximately equal amounts of 2 chemical compounds, known as cannabidiol (CBD) and tetrahydrocannabinol
(THC). Nabiximols 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 MS and who have not responded adequately to other anti-spasticity medication in the United Kingdom
and many countries within and outside the EU.
The sponsor is testing a single dose of nabiximols on various measures of spasticity in participants with MS who are currently taking stable doses
of nabiximols in combination with other antispasticity medications. In order to participate, MS patients will stop taking their prescribed nabiximols
for a total duration of 7 days but continue to take other antispasticity medications.
The study will consist of two treatment periods, where participants will receive a single dose of either nabiximols or a placebo in an order
determined by chance. Participants may receive a placebo which looks like nabiximols but contains no medication to allow the sponsor to see if
nabiximols works better than the placebo.
In each of the treatment periods, 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 72 hours between single doses so that the study
medicine is cleared from the participants body before administration of the next dose.REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0021
Date of REC Opinion
18 Feb 2021
REC opinion
Favourable Opinion