Efficacy, safety, and tolerability of low sodium oxybate for nocturnal cluster headache attacks in chronic cluster headache: protocol for a phase II randomized, double-blind, placebo-controlled, trial (SUNCET)

Key Points

• This research aims to evaluate the efficacy, safety, and tolerability of low sodium oxybate in treating nocturnal cluster headache attacks.
• Phase II randomized, double-blind design
• Participants will receive either low sodium oxybate or placebo
• Evaluation of headache frequency and severity during treatment
• Expected improvement in nocturnal cluster headache frequency with low sodium oxybate
• Assessment of treatment safety and side effects
• Comparison of outcomes between treatment and placebo groups