Muscle Spasticity Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled Phase III Trial to Determine the Efficacy and Safety of a Standardised Oral Extract of Cannabis Sativa for the Symptomatic Relief of Muscle Stiffness and Pain in Multiple Sclerosis.
Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis
sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness
and pain in multiple sclerosis for a period of 12 weeks.
Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during
previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised
≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at
baseline.
Study treatment:
Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing
between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous
antispasticity and analgesic medication.
Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic
medication.
Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg
THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on
tolerability. Treatment duration: 12 weeks.
Study sites: 20 neurological clinics in the United Kingdom.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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