A phase II randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of an oral solution of 9-Δ tetrahydrocannabinol/cannabidiol (THC/CBD) in multiple sclerosis patients with chronic neuropathic pain

Chronic neuropathic pain due to multiple sclerosis (MS)

Efficacy: Change in pain intensity as measured by the Numeric Rating Scale (NRS 0-10) between baseline (Day 1) and 4 weeks of optimized treatment (corresponding to Week 6 visit); the mean of the last four available ratings in the 7 days prior to a study visit will be considered.

Efficacy: Proportion of patients who achieved at least a 30% reduction in their pain NRS 0-10 score after 4 weeks of optimized treatment, Efficacy: Proportion of patients who achieved at least a 50% reduction in their pain NRS 0-10 score after 4 weeks of optimized treatment, Efficacy: Change in pain intensity as measured by the NRS 0-10 between baseline (Day 1) and 12 weeks of optimized treatment, Efficacy: Proportion of patients who achieved at least a 30% reduction in their pain NRS 0-10 score after 12 weeks of optimized treatment, Efficacy: Proportion of patients who achieved at least a 50% reduction in their pain NRS 0-10 score after 12 weeks of optimized treatment, Efficacy: Proportion of patients who achieved at least a 30% reduction in spasticity NRS 0-10 score after 4 weeks of optimized treatment., Efficacy: Proportion of patients who achieved at least a 30% reduction in spasticity NRS 0-10 score after 12 weeks of optimized treatment., Efficacy: Change in spasticity symptom measured by the NRS 0-10 between baseline (Day 1) and 4 weeks of optimized treatment and baseline and 12 weeks of optimized treatment (0: No spasticity - The patient experiences no increase in muscle tone or involuntary muscle spasms; 10: Worst possible spasticity - The patient experiences extreme muscle stiffness, severe spasms, and significant difficulty with movement), Efficacy: Change in Pittsburgh Sleep Quality Index (PSQI) component scores and global score between baseline (Day 1) and 4 weeks of optimized treatment and baseline and 12 weeks of optimized treatment, Efficacy: Change in EuroQol 5-Dimensions, 5-Levels (EQ-5D-5L) index score between baseline (Day 1) and 12 weeks of optimized treatment, Efficacy: Change in EQ-5D-5L visual analogue scale (VAS) score between baseline (Day 1) and 12 weeks of optimized treatment, Efficacy: Proportion of patients reporting improvement in their condition with Patient Global Impression of Change (PGIC) scale after 4 and 12 weeks of optimized treatment, Efficacy: Change in the Expanded Disability Status Scale (EDSS) score between baseline (Day 1) and 4 weeks of optimized treatment and from baseline and 12 weeks of optimized treatment, Efficacy: Change in the Nine-Hole Peg test (NHPT) completion time from baseline (Day 1) and 4 weeks of optimized treatment and between baseline and 12 weeks of optimized treatment., Efficacy: Reduction of at least a 30% Neuropathic Pain Symptom Inventory (NPSI) score after 4 and 12 weeks of optimized treatment., Safety: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AE) leading to study discontinuation. Clinically relevant abnormalities in vital signs, 12-lead electrocardiogram (ECG) and laboratory parameters will be reported as AEs.

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