Lacosamide effects on pain management in patients with multiple sclerosis: A randomized, double-blind, placebo-controlled clinical trial.

Background

Multiple sclerosis (MS) frequently presents with pain, a debilitating symptom for which effective treatments are scarce. This study aims to assess the potential analgesic effects of Lacosamide in individuals with MS.

Methods

This randomized, double-blind, placebo-controlled trial investigated the efficacy of lacosamide in adult patients with definite MS and moderate-to-severe MS-related pain (Brief Pain Inventory [BPI] severity score ≥4). Participants were randomly assigned (1:1) to receive either lacosamide or a matching placebo for 12 weeks. Lacosamide was titrated weekly to a maximum tolerated dose of 200 mg twice daily. The primary outcome measure was the change in BPI pain severity score from baseline to month three. Secondary outcome measures included pain interference (BPI), neuropathic pain symptom inventory (NPSI), patient global impression of change (PGIC), quality of life (SF-36), and safety assessments.

Results

The study demonstrated balanced baseline characteristics between treatment groups. Compared to placebo, lacosamide led to a statistically significant decrease in pain severity (P = 0.001), achieving targets of pain below 4 and a 50% reduction. Pain interference and total NPSI scores also improved significantly (P = 0.025; ∼70% reduction). By month three, 90.0% of lacosamide patients reported clinical improvement vs. 37.5% in placebo (P < 0.001). SF-36 scores improved (P = 0.022). No serious adverse events occurred.

Conclusions

Lacosamide (up to 400 mg/day) significantly reduces chronic pain severity and interference in MS patients, improving their global impression of change and quality of life. With an acceptable safety profile, it's an effective treatment option for MS-related pain.