Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2021-12-08
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients
NCT05411978
A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
NCT02901756
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
NCT04418765
Efficacy, Tolerability, and Safety of DFN-15
NCT03009019
Eptinezumab in Adults With Migraine and Medication Overuse Headache
NCT04772742
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Idebenone and placebo were provided by Qilu Pharmaceutical Company Limited, China. Placebo consisted of the same ingredients as verum-instead idebenone, they classify as fit for human consumption in the China and without any known effect on migraine.
The design of this double-blind, randomized, placebo-controlled trial followed the IHS Committee on Clinical Trials in Migraine guidelines, 8 current EU guidelines on Good Clinical Practice, and the Declaration of Helsinki. It was approved by Neurology Department, the Second Affiliated Hospital, School of Medicine, Zhejiang University. This study is supported by the following funding sources: the Zhejiang Provincial Natural Science Foundation of China (Grant No. LY19H090025, Grant No. LQ15H090003), the National Natural Science Foundation of China (Grant No. 81101157). The study is also supported by Qilu Pharmaceutical Company Limited, China (http://www.qilu-pharma.com); the use of idebenone in migraine, is patent pending in the China. Dr. Kaiming Liu do not receive honoraria from the sponsor of the study.
Exclusion criteria includes subjects who previously failed idebenone therapy for migraine prophylaxis, those who previously discontinued idebenone due to adverse events, those who are taking idebenone or had taken idebenone within 14 days prior to enrollment, and subjects with continuous headaches. Subjects will be equally randomized to be treated with 90 mg/day idebenone, 270 mg/day idebenone, or placebo for 3 months.
At the first visit, patients will receive placebo for a 1-month base-line. At the second visit, they will be randomized to be treated with 90 mg/day idebenone, 270 mg/day idebenone, or placebo for next 3 months if they have presented at least one migraine attack.
The primary objective is to assess whether at least 1 dose of Idebenone is superior to placebo in overall mean change from baseline of 4-week migraine headache days (MHD) during double-blind treatment. Key secondary outcome variables will be change of migraine attack frequency, migraine moderate/severe headache days, the proportion of subjects with at least 50%, at least 75%, and 100% reduction in migraine days, mean severity of migraine, acute treatment utilization, quality of life related to episodic migraine as measured by the The Role Function Physical subscale in The Migraine-Specific Quality of Life questionnaire (MSQ v2.1), migraine-related disability as measured by The Headache Impact Test (HIT-6), Patient Global Impression of Severity (PGI-S) scores, and Migraine Disability Assessment (MIDAS) scores from baseline of 4-week to the entire double-blind treatment phase.
Responders for attack frequency (50% reduction) will be calculated and the number-needed-to-treat (NNT) determined. Patients will be interviewed about adverse events at each visit. Statistical analysis will be done on an intention-to-treat population applying the last visit carried forward method. Mann-Whitney U test will be used for differences between groups, 2 test for 22 contingency tables of responder rate, general linear mixed model for evolution over time. Significance level is p\<0.05, after accounting for multiple comparisons. SPSS will be used.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
90mg Idebenone
Placebo by mouth, three times a day for 1 months； Idebenone 30mg table by mouth, three times a day for next 3 months
Placebo
Placebo oral tablet, three times a day
90mg Idebenone
Idebenone 30 MG Oral Tablet, three times a day
270mg Idebenone
Placebo by mouth, three times a day for 1 months； Idebenone 90mg table by mouth, three times a day for next 3 months
Placebo
Placebo oral tablet, three times a day
270mg Idebenone
Idebenone 90 MG Oral Tablet, three times a day
Placebo
Placebo by mouth, three times a day for 4 months
Placebo
Placebo oral tablet, three times a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo oral tablet, three times a day
90mg Idebenone
Idebenone 30 MG Oral Tablet, three times a day
270mg Idebenone
Idebenone 90 MG Oral Tablet, three times a day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
3. Two to eight attacks per month, 5 days/month of interval headaches.
4. No over consumption of acute anti-migraine medication.
5. No other prophylactic medication (washout 3 months).
6. No serious organic or psychiatric disease.
7. Only women with contraceptive protection.
Exclusion Criteria
2. Subjects previously discontinued idebenone due to adverse events.
3. Subjects are taking idebenone or had taken idebenone within 14 days prior to enrollment.
4. Subjects with continuous headaches.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kaiming Liu
Deputy chief physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kaiming Liu, MD & PHD
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiming Liu
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kaiming Liu
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-675
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.