Effect of Nicotinic Acid as add-on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine: A Randomized, Double-blind, Placebo-controlled Trial
This is a prospective single center, randomized, double-blind, 3 arm placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive Nicotinic Acid Extended-release tablet 500 mg or 1000 mg or placebo for 12 weeks. The safety and efficacy outcome measures will be assessed at baseline and 12 weeks.
• Patients suffering from migraine with or without aura according to International ICHD 3 criteria
• Patients with 4-15 qualified migraine attacks per month during the four weeks of the Baseline Phase
• History of headache for at least 1 year
• Age at onset of migraine should be less than 50 years
• Headache intensity: Moderate to severe (Visual analogue scale score at least 3)
• Consuming one β Blocker as prophylaxis