Registry of Trialsclinicaltrials.gov
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
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
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.
Epistemonikos ID: 202cfae6648a835ada2f560c245f3ff106b02369
First added on: Jun 26, 2015