Idebenone for the Preventive Treatment of Migraine

NCT04151472 | Recruiting Phase 3 DMC

• 1 other identifier: 2019-675
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Disorders; Headache Disorders

Keywords

Migraine Prophylaxis; Mitochondrial Dysfunction; Idebenone; Individualized Treatment

Outcome Measures

Primary Outcomes (1)

• The change of migraine attack frequency

  The change of migraine attack frequency in month 4 compared with baseline. Headache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary. Degree of pain and results of treatment are scored by visual analogue scale(VAS).

  month 0, month 1, month 2, month 3, month 4

Secondary Outcomes (6)

• The change of days with headache

  month 0, month 1, month 2, month 3, month 4

• Mean severity of migraine

  month 0, month 1, month 2, month 3, month 4

• The change of days with nausea/vomiting

  month 0, month 1, month 2, month 3, month 4

• Mean duration of migraine

  month 0, month 1, month 2, month 3, month 4

• 50% Responder rate for attack frequency

  month 0, month 1, month 2, month 3, month 4

Study Arms (3)

90mg Idebenone

EXPERIMENTAL

Placebo by mouth, three times a day for 1 months； Idebenone 30mg table by mouth, three times a day for next 3 months

Drug: Placebo; Drug: 90mg Idebenone

270mg Idebenone

EXPERIMENTAL

Placebo by mouth, three times a day for 1 months； Idebenone 90mg table by mouth, three times a day for next 3 months

Drug: Placebo; Drug: 270mg Idebenone

Placebo

PLACEBO COMPARATOR

Placebo by mouth, three times a day for 4 months

Drug: Placebo

Interventions

Placebo DRUG

Placebo oral tablet, three times a day

270mg Idebenone; 90mg Idebenone; Placebo

90mg Idebenone DRUG

Idebenone 30 MG Oral Tablet, three times a day

Also known as: Shenwei

90mg Idebenone

270mg Idebenone DRUG

Idebenone 90 MG Oral Tablet, three times a day

Also known as: Shenwei

270mg Idebenone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of episodic migraine.
• Patients (18-65 years) were eligible if they met International Headache Society (IHS) criteria for episodic migraine with/ without aura with a migraine history 1 year
• Two to eight attacks per month, 5 days/month of interval headaches.
• No over consumption of acute anti-migraine medication.
• No other prophylactic medication (washout 3 months).
• No serious organic or psychiatric disease.
• Only women with contraceptive protection.

You may not qualify if:

• Clinical diagnosis of chronic migraine.
• Subjects previously discontinued idebenone due to adverse events.
• Subjects are taking idebenone or had taken idebenone within 14 days prior to enrollment.
• Subjects with continuous headaches.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Kaiming Liu

Hangzhou, Zhejiang, 370001, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 28132202 BACKGROUND

• 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.

  PMID: 29298622 BACKGROUND

• 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.

  PMID: 25916335 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.

  PMID: 24331360 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.

  PMID: 23030537 BACKGROUND

• 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.

  PMID: 21586650 BACKGROUND

• 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.

  PMID: 20065258 BACKGROUND

• 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.

  PMID: 11972582 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.

  PMID: 26639834 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.

  PMID: 20726168 BACKGROUND

• 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.

  PMID: 21788663 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders; Mitochondrial Diseases

Interventions

idebenone

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kaiming Liu, MD & PHD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Kaiming Liu, MD & PHD

CONTACT

+8615068862055; 2314411@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 5, 2019
• Study Start: December 8, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)