Idebenone for the Preventive Treatment of Migraine

Summary

Idebenone improves energy metabolism similarly to Coenzyme Q10, which is effective in migraine prophylaxis. The investigators compare idebenone (90 mg/day, 270 mg/day) and placebo in 180 migraine patients in a double-blind, randomized, placebo-controlled, multicenter trial to study whether Idebenone is superior to placebo in the prevention of episodic migraine with or without aura.

Timeline

Start

2021-12-08

Primary completion

2025-12-31

Completion

2025-12-31

Publications

• Background Yorns WR Jr, Hardison HH. Mitochondrial dysfunction in migraine. Semin Pediatr Neurol. 2013 Sep;20(3):188-93. doi: 10.1016/j.spen.2013.09.002.
• Background Markley HG. CoEnzyme Q10 and riboflavin: the mitochondrial connection. Headache. 2012 Oct;52 Suppl 2:81-7. doi: 10.1111/j.1526-4610.2012.02233.x.
• Background Borkum JM. Migraine Triggers and Oxidative Stress: A Narrative Review and Synthesis. Headache. 2016 Jan;56(1):12-35. doi: 10.1111/head.12725. Epub 2015 Dec 7.
• Background Koreshkina MI. [The use of noben (idebenone) in the complex treatment of episodic and chronic migraine]. Zh Nevrol Psikhiatr Im S S Korsakova. 2010;110(6):98-101. No abstract available. Russian.
• Results Dalla Volta G, Carli D, Zavarise P, Ngonga G, Vollaro S. P026. Pilot study on the use of coenzyme Q10 in a group of patients with episodic migraine without aura. J Headache Pain. 2015 Dec;16(Suppl 1):A186. doi: 10.1186/1129-2377-16-S1-A186. No abstract available.
• Results Dahri M, Tarighat-Esfanjani A, Asghari-Jafarabadi M, Hashemilar M. Oral coenzyme Q10 supplementation in patients with migraine: Effects on clinical features and inflammatory markers. Nutr Neurosci. 2019 Sep;22(9):607-615. doi: 10.1080/1028415X.2017.1421039. Epub 2018 Jan 3.
• Results Gaul C, Diener HC, Danesch U; Migravent(R) Study Group. Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial. J Headache Pain. 2015;16:516. doi: 10.1186/s10194-015-0516-6. Epub 2015 Apr 3.
• Results Slater SK, Nelson TD, Kabbouche MA, LeCates SL, Horn P, Segers A, Manning P, Powers SW, Hershey AD. A randomized, double-blinded, placebo-controlled, crossover, add-on study of CoEnzyme Q10 in the prevention of pediatric and adolescent migraine. Cephalalgia. 2011 Jun;31(8):897-905. doi: 10.1177/0333102411406755. Epub 2011 May 17.
• Results Brenner SR. Mitochondrial DNA haplogroups influence the therapeutic response to riboflavin in migraineurs. Neurology. 2010 Jan 12;74(2):182-3; author reply 183. doi: 10.1212/WNL.0b013e3181c77678. No abstract available.
• Results Rozen TD, Oshinsky ML, Gebeline CA, Bradley KC, Young WB, Shechter AL, Silberstein SD. Open label trial of coenzyme Q10 as a migraine preventive. Cephalalgia. 2002 Mar;22(2):137-41. doi: 10.1046/j.1468-2982.2002.00335.x.
• Results Klopstock T, Yu-Wai-Man P, Dimitriadis K, Rouleau J, Heck S, Bailie M, Atawan A, Chattopadhyay S, Schubert M, Garip A, Kernt M, Petraki D, Rummey C, Leinonen M, Metz G, Griffiths PG, Meier T, Chinnery PF. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy. Brain. 2011 Sep;134(Pt 9):2677-86. doi: 10.1093/brain/awr170. Epub 2011 Jul 25.

Drugs

Indications