Original
Efficacy and Safety of Nicotinic Acid for Prophylaxis of Episodic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
*Ta-din H,1 Rahman MS,2 Ayshi SA,3 Akter T4
- *Dr. Hudia Ta-din, MD (Pharmacology), Lecturer, Department of Pharmacology, Shaheed Syed Nazrul Islam Medical College, Kishoreganj, Bangladesh hudiatadin@gmail.com. ORCID: https://orcid.org/0009-0004-0315-8329
- Dr. Md. Sayedur Rahman, M Phil, FCPS, Professor, Department of Pharmacology, Bangladesh Medical University, Dhaka, Bangladesh. ORCID: https://orcid.org/0000-0002-5960-0161
- Dr. Shimu Akter Ayshi, MD (Pharmacology), Assistant professor, Jahurul Islam Medical college, Kishoreganj, Bangladesh. ORCID: https://orcid.org/0009-0006-6523-7705
- Dr. Taslima Akter, MD (Laboratory medicine), Clinical pathologist, Shaheed Syed Nazrul Islam Medical College, Kishoreganj, Bangladesh. ORCID: https://orcid.org/0009-0006-8888-311X
*For correspondence
Abstract
Background: Nicotinic acid is a water-soluble vitamin used in dyslipidaemia.
Objective: In this study, 2 doses of nicotinic acid were compared with placebo to explore the effect of this drug in prophylaxis of episodic migraine.
Methods: In this phase 2 trial, adults with episodic migraine attended at Outpatient Department of Bangladesh Medical University were recruited. After a 4-weeks of baseline, 66 eligible participants were randomized to oral Nicotinic acid 500 mg or 1000 mg extended-release tablet or placebo a day for 12 weeks. The primary endpoint was changes in the number of migraine days per 4 weeks from the baseline, was assessed and compared. Trial was registered in the ClinicalTrials.gov with the trial ID number NCT05846373
Results: Nicotinic acid extended-release tablet 500 mg and 1000 mg reduced the number of migraine days per 4 weeks significantly over 1st week to 8th week of double-blind treatment phase (p value < 0.0001 for both Niacin 500 mg and 1000 mg than that of the baseline). Reductions were maintained over 9th to 12th weeks. The number of migraine days were 2.55 ± 2.19 in Niacin 500 mg arm and 2.11 ± 2.05 in Niacin 1000 mg arm were significantly lower than placebo (p = 0.004 among the 3 arms). Most common Treatment-emergent adverse events (TEAEs) experienced in Niacin arm was flushing (42% in 1000 mg arm and 25% in 500 mg arm). They were self-limiting and not much different in Nicotinic acid arms than placebo (p > 0.05).
Conclusion: Nicotinic acid was effective and well-tolerated in prophylaxis of episodic migraine.
[Shaheed Syed Nazrul Islam Med Col J 2026, July; 11 (2):189-198]
DOI: https://www.doi.org/10.69699/ssnimcj.2026.11.2.12