This study will be conducted to evaluate the effect of multiple doses of nabiximols compared
with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs
(Lower Limb Muscle Tone-6 [LLMT-6]) in participants with multiple sclerosis (MS). LLMT-6 is
defined as the average of the 6 individual Modified Ashworth Scale (MAS)-transformed scores
of knee flexors, knee extensors, and plantar flexors on both sides of the body.
Each period of this multicenter, randomized, double-blind, placebo-controlled, 2-treatment,
2-period, crossover trial includes a 7-day Baseline period, a 3-week treatment period
(comprising a 2-week titration phase and a 1-week maintenance phase).
Eligible participants will enter the 7-day baseline period of each treatment period. During
baseline, participants will maintain their optimized oral MS antispasticity medication
regimen and record their 11-point Numerical Rating Scale (NRS) spasticity score and spasm
count using an electronic daily diary. On Day 1, eligible participants will be randomized to
1 of 2 treatment sequences, each composed of 2 treatment periods, with administration of
multiple doses of nabiximols or placebo in a 1:1 ratio.
Participants will be advised to titrate the investigational medicinal product (IMP),
beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the
first 14 days of treatment. Participants should continue at the same dose level achieved at
the end of the titration phase ±1 spray divided into a morning dose and an evening dose for
the remainder of the treatment period.
Lower limb muscle tone, health-related quality of life, safety, tolerability, and
pharmacokinetics will be evaluated during the treatment period.
Participants who complete the trial will participate for a total of approximately 11 weeks
(77 days), including the 7-day baseline period.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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