Clinical trial NCT05411978: Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Parallel Pilot Study to Evaluate Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine Prophylaxis
Mitochondrial Dysfunction
Idebenone Individualized Treatment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multi-center, prospective, double-blind randomized controlled trial on a sample of patients with migraine. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits.


Eligibility criteria: Inclusion Criteria:

* Male or female participants ages 18 to 65 years;
* At least a 1-year history of migraine with or without aura is consistent with a diagnosis according to the ICHD-3;
* Migraine onset before age 50 years;
* History of 4 to 15 migraine attacks days per month in each of the 3 months prior to the screening visit;
* The number of headache attacks \<15 days/month during the 3 months prior to the screening visit;
* Be willing to use effective contraception during the trial and for 28 days after the end of the last dose;
* Sign the informed consent form.
* History of 4 to 14 migraine attacks days within 4 weeks during the screening visit.
* The number of headache attacks \<14 days/month within 4 weeks during the screening visit;
* Completed at least 23 days of the electronic diary within 28 days during the screening visit. And the participant is to be able to read, understand and complete the study questionnaire and headache diary;
* Understand and comply with the study procedures and methods, and voluntarily participate in this study.

Exclusion Criteria:

* Participants diagnosed with probable migraine by ICHD-3
* Current or previous diagnosis of primary, secondary, or painful cranial neuropathy other than migraine (diagnostic criteria according to ICHD-3)
* Prior ineffectiveness after adequate treatment with more than 2 medications, which are listed below: Divalproex, sodium valproate; topiramate; beta-blockers; Tricyclic antidepressants; serotonin-norepinephrine reuptake inhibitors; Flunarizine, Verapamil; Lisinopril, Candesartan.

Definition of failure to treat: frequency, duration, and severity of headache 6 weeks after administration of the degree of the above drug does not decrease.

* Use of other devices or prohibited medications such as painkillers containing opioids for the treatment of migraine within 2 months before or during the screening visit
* Therapeutic injections of Botulinum toxin in the head, face, or neck within 4 months before screening and during the study periods
* Simultaneous use of 2 or more drugs within 2 months before or during the screening visit may be prophylactic Medications for migraine effects (if used only 1 prophylactic drug, the dose must be stable for 2 months before the screening visit and throughout the study period)
* The following situations occur within 2 months before the screening period begins: take ergotamines or triptans at least 10 days per month, or take non-steroidal anti-inflammatory drugs (NSAID) only every month ≥15 days, NSAID combination ≥10 days, or use opioid or barbiturate analgesics ≥4 days per month;
* Participants use the prohibited drugs such as painkillers containing opioids, devices, or regimens during treatment.
* History of active chronic pain syndrome (e.g., fibromyalgia, chronic pelvic pain, face Pain, etc.);
* History of mental illness (e.g., schizophrenia or bipolar disorder) or Patient Health Questionnaire (PHQ-9) score ≥15. If the participant has a history of anxiety or depression (PHQ-9 score \< 15) and takes no more than one psychotropic drug, the participant will be allowed to enter. (participant must take a steady dose of treatment within 3 months before the screening visit)
* Severe neurological disorders other than migraines (including febrile seizures);
* History of a malignant tumor within 5 years before the screening visit, except for non-melanoma skin cancer, cervical or ductal carcinoma in situ;
* The screening visit meets any of the following laboratory test values: Alanine transaminase (ALT) or aspartate aminotransferase(AST) \>1.5×ULN, or total bilirubin \>1.5×ULN (except for participants diagnosed with Gilbert syndrome);
* History of myocardial infarction, stroke, or transient ischemic attack, unstable angina or coronary bypass surgery within 12 months before the screening visit
* Expose participants to significant risk or confuse the study
* Based on clinical interviews or C-SSRS, the investigator believes that the subject has self-harmed or harmed him Human risk;
* History of drugs or alcohol abuse within 12 months before the screening visit
* Pregnant, planning pregnancy, or Lactating women;
* Fertile female participants are unwilling to use an effective contraceptive during the study period Method.

Infertile women as follows: history of menopause, age ≥ 55 years, menopause ≥12 months.

Age \< 55 years, free from spontaneous menstruation for at least 2 years. Age \< 55, has spontaneous menstruation in the past 1 year, but currently amenorrhea (e.g., Spontaneous or secondary to hysterectomy), and postmenopausal gonadotropin levels gonadotropin Luteinizing hormone (LH), follicle-stimulating Hormone\> 40 IU/L or postmenopausal estradiol level \<5 ng/dL History of bilateral oophorectomy, hysterectomy, or bilateral salpingectomy

* Participated in other clinical trials within the first 3 months
* Known allergy to Idebenone or any of its ingredients(e.g., lactose intolerant)；
* The participants are employees or immediate family members of the research center (parents, spouses, siblings, or children).

Primary outcomes:
measure: Changes in the migraine days per 4 weeks relative to the baseline.
timeFrame: baseline, 4,8,12 weeks
Secondary outcomes:
measure: Frequency of headache attacks per 4 weeks as compared to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Changes in the moderate / severe headache days per 4 weeks relative to the baseline
timeFrame: baseline,at 4,8,12 weeks
measure: Percentage of participants with at Least 50%, 75% and 100% reduction in the Number of Days of Migraine Attacks per 4 weeks.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in frequency of acute drug use per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in dose of acute drug use per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in peak headache pain intensity per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in average headache intensity per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in cumulative hours of moderate/severe headache pain per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in the number of without symptoms days per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in the number of without headache days per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Fatigue Severity Scale (FSS) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Modified Migraine Disability Assessment Scale score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Headache Impact Test(HIT-6) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Migraine-Specific Quality-of-Life Questionnaire, Version 2.1 (MSQ Version 2.1) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Patient Global Impression of Change (PGIC).
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Patient Health Questionnaire-9 (PHQ-9) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The General Anxiety Disorder-7(GAD-7) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Functional Impairment Scale (FIS) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) scores per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
measure: Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) score per 4 weeks relative to baseline.
timeFrame: baseline,at 4,8,12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yonggang Wang
Study officials:
References: