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

BSMMU/2022/11548

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.

2022-11-25

2024-01-10

2024-01-10

Recruiting

Early phase I

66

Inclusion Criteria: 1. Patients suffering from migraine with or without aura according to International ICHD 3 criteria 2. Patients with 4-15 qualified migraine attacks per month during the four weeks of the Baseline Phase 3. History of headache for at least 1 year 4. Age at onset of migraine should be less than 50 years 5. Headache intensity: Moderate to severe (Visual analogue scale score at least 3) 6. Consuming one β Blocker as prophylaxis Exclusion Criteria: 1. Pregnancy and lactation 2. Known case of any hepatic, psychiatric diseases except depression, diabetes mellitus (DM), gout, peptic ulcer disease 3. Known hypersensitivity to niacin 4. Consumption of certain drugs Lipid lowering agents Antiplatelet and Anticoagulants Antihypertensive medications Alcohol or other abusive drugs 5. Plasma Nicotinic acid level \> 8.45 µg/mL

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

2024-01-17