migraine
Conditions
Interventions
experimental group 1:idebenone 30mg + placebo 60mg tid
experimental group 2:idebenone 90mg tid
control group:idebenone placebo 90mg tid
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 65 years old (including both ends); 2. History of migraine (with or without aura) for at least 12 months according to the third edition of the International Classification of Headache Diseases ICHD-3(Headache Classification Committee of the International Headache Society, 2018); 3. The age of onset of migraine for the first time is less than 50 years; 4. Migraine frequency: >= 4 and = 4 and < 14 migraine days per 4 weeks during the screening phase (evaluation is based on appendix 14 the eDiary); 9. Headache frequency: < 14 headache days within 4 weeks of the screening phase; 10. Demonstrated at least 80% compliance within 4 weeks of the screening phase(completing eDiary items for at least 23 out of 28 days during the screening phase),and the investigator believes that the subject can read, understand, and complete the research questionnaire and headache diary; 11. Understand and abide by the research procedures and methods, participate in this trial voluntarily, and sign a written informed consent form, agree to enter the drug randomized double-blind placebo-controlled trial.
Exclusion criteria
Exclusion criteria: 1. Current and previous diagnoses are other primary headaches, secondary headaches or painful cranial neuropathy except migraine (diagnostic criteria are based on ICHD-3, 2018 definition) 2. No therapeutic response with > 2 of the following 7 medication categories after an adequate therapeutic. These medication categories are: ?Category 1: Divalproex sodium, sodium valproate ?Category 2: Topiramate ?Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol) ?Category4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline) ?Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine, duloxetine, milnacipran) ?Category 6: Flunarizine, verapamil ?Category 7: Lisinopril, candesartan No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks .The following scenarios do not constitute lack of therapeutic response: ?Lack of sustained response to a medication ?Failure to tolerate a therapeutic dose 4)Used a prohibited medication, device, or procedure within 2 months prior to the start of the screening phase or during the screening phase (Refer to Section 5.7.2 banned drugs/treatment) 5)Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline phase or during the baseline phase(?Dysport?Botox?Xeomin?Myobloc? JeuveauTM) 6)Within 2 months before the start of the baseline period or at the same time during the baseline period, two or more drugs that may have migraine prevention effects are used (see Appendix 3. Migraine preventive drugs list) (if only one preventive drug is used) , The dose must be stable within 2 months before the baseline period and throughout the study period); 7)Taken the following for any indication in any month during the 2 months prior to the start of the screening phase ?Ergotamines or triptans on = 10 days per month, or ?Non-steroidal anti-inflammatory drugs(NSAIDs )on = 15 days per month, Non-steroidal anti-inflammatory drug compound preparation= 10 days per month or ?opioid or barbiturate analgesics= 4 days per month. 8)Anticipated to use the following, banned drugs, devices or programs during the double-blind treatment (Refer to Section 5.7.2 banned drugs/treatment for details ) 9)Subjects have the Active chronic pain syndromes (such as fibromyalgia, chronic pelvic pain, facial pain, etc.) 10) History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or 7.2.6 Patient Health Questionnaire (PHQ-9) score = 15 points ,if the subject has a history of anxiety or depression (PHQ-9 score 1.5×(upper limit of normal, ULN), or ?Total
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and effect; | — |
Countries
China
Contacts
Public ContactWang Yonggang
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed