Nortriptyline Compared With Amitriptyline for Migraine Prevention at SQUH

Summary

This study will compare nortriptyline and amitriptyline for preventing migraine attacks in adults receiving care at Sultan Qaboos University Hospital in Oman. The researchers will assess whether the medicines differ in their effect on migraine frequency, side effects, and continued treatment use. Ninety adults with episodic migraine will be assigned by chance to receive either nortriptyline or amitriptyline, with 45 participants in each group. After completing a four-week baseline headache diary, participants will take the assigned medicine each evening for 16 weeks. Treatment will start at 10 mg nightly and increase gradually toward 50 mg nightly when tolerated. Lower doses will be permitted for safety or tolerability reasons. Participants and the clinical assessment team will not know which medicine has been assigned. The main outcome will be the change in migraine days during the final four weeks of treatment compared with baseline. Other outcomes will include headache days, use of medicines for acute headache, headache impact, migraine-related disability, adverse events, and stopping treatment because of adverse events. Treatment will usually be tapered over two weeks, with a final safety assessment at week 20 after randomization. Participation will last approximately 24 weeks, including the baseline period. Appropriate acute migraine treatment will remain available throughout the study.

Timeline

Start

2027-05

Primary completion

2030-05

Completion

2030-12

Publications

• Background Roghani M, Ghaedi G, Iranzadeh S, Golezar MH, Afshinmajd S. Efficacy and safety of venlafaxine versus nortriptyline for the preventive treatment of migraine: A double-blind randomized clinical trial. Clin Neurol Neurosurg. 2024 Aug;243:108400. doi: 10.1016/j.clineuro.2024.108400. Epub 2024 Jun 17.
• Background Goncalves AL, Martini Ferreira A, Ribeiro RT, Zukerman E, Cipolla-Neto J, Peres MF. Randomised clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention. J Neurol Neurosurg Psychiatry. 2016 Oct;87(10):1127-32. doi: 10.1136/jnnp-2016-313458. Epub 2016 May 10.
• Background Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Houle TT, Hoek TCVD, Martinelli D, Terwindt GM; International Headache Society Clinical Trials Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults. Cephalalgia. 2020 Sep;40(10):1026-1044. doi: 10.1177/0333102420941839. Epub 2020 Jul 28.

Drugs

Indications