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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idebenone 30 mg+ Placebo 60 mg | Placebo Comparator | Idebenone 30 mg+ placebo 60 mg TID Oral ,for 12 weeks |
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| Idebenone 90 mg | Experimental | Idebenone 90 mg TID Oral ,for 12 weeks |
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| Placebo 90 mg | Placebo Comparator | Placebo 90 mg TID Oral,for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idebenone+ placebo | Drug | Participants will receive Idebenone 30 mg+ placebo 60 mg for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the migraine days per 4 weeks relative to the baseline. | Days with migraine in the last four weeks from a daily headache diary. | baseline, 4,8,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of headache attacks per 4 weeks as compared to baseline. | Headache attack as any consistent headache attacks or the use of specific headache drugs. | baseline,at 4,8,12 weeks |
| Changes in the moderate / severe headache days per 4 weeks relative to the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YONGGANG WANG | Contact | 15010066622 | w100yg@163.com | |
| YAQING ZHANG | Contact | 13910760399 | Zhyq0401@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonggang Wang | Recruiting | Beijing | 100050 | China |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C036619 | idebenone |
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| Idebenone | Drug | Participants will receive Idebenone 90 mg for 12 weeks. |
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| Placebo | Drug | Participants will receive Placebo 90 mg for 12 weeks |
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Moderate / severe headache days as a day in which moderate or severe pain persists for at least 4 hours, or headache lasts for one day after successful medication for acute headache. |
| baseline,at 4,8,12 weeks |
| Percentage of participants with at Least 50%, 75% and 100% reduction in the Number of Days of Migraine Attacks per 4 weeks. | The response rate as the percentage reduction in the frequency of migraine attacks (or days of migraine, or days of moderate or severe headache) compared with the baseline during each treatment period. | baseline,at 4,8,12 weeks |
| Change in frequency of acute drug use per 4 weeks relative to baseline. | The allowed medications include the following categories of drugs: triptans, ergots, opioids, analgesics (including acetaminophen), NSAIDs (including aspirin), and antiemetics. | baseline,at 4,8,12 weeks |
| Change in dose of acute drug use per 4 weeks relative to baseline. | The allowed medications include the following categories of drugs: triptans, ergots, opioids, analgesics (including acetaminophen), NSAIDs (including aspirin), and antiemetics. | baseline,at 4,8,12 weeks |
| Change in peak headache pain intensity per 4 weeks relative to baseline. | Participates record the maximum intensity of daily headaches and any medication used. The Visual Analogue Scale (VAS) can be used instead of or in conjunction with a 4-level classified rating scale. | baseline,at 4,8,12 weeks |
| Change in average headache intensity per 4 weeks relative to baseline. | Four-point rating scale to evaluate the headache intensity of each migraine day--painless, mild, moderate, or severe. The Visual Analogue Scale (VAS) can be used instead of or in conjunction with a 4-level classified rating scale. | baseline,at 4,8,12 weeks |
| Change in cumulative hours of moderate/severe headache pain per 4 weeks relative to baseline. | The cumulative number of hours of moderate / severe pain calculated by electronic headache diaries. If an attack occurs before going to bed and when you wake up, the amount of sleep also counts as the number of headache hours. | baseline,at 4,8,12 weeks |
| Change in the number of without symptoms days per 4 weeks relative to baseline. | The number of days without aura, prodromal symptoms, headaches, pain, and subsequent symptoms by headache diary. | baseline,at 4,8,12 weeks |
| Change in the number of without headache days per 4 weeks relative to baseline. | The number of days without headaches by headache diary. | baseline,at 4,8,12 weeks |
| Change in The Fatigue Severity Scale (FSS) score per 4 weeks relative to baseline. | The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on you. The FSS is a short questionnaire that requires you to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A higher score indicates greater severity. | baseline,at 4,8,12 weeks |
| Change in The Modified Migraine Disability Assessment Scale score per 4 weeks relative to baseline. | The Modified Migraine Disability Assessment Scale is a 7-item questionnaire designed. The score is the sum of missed work or school days, days at work or school plus days of household work where productivity was reduced by half or more, missed household work days, and missed non-work activity days due to headaches in the last 1 months. | baseline,at 4,8,12 weeks |
| Change in The Headache Impact Test(HIT-6) score per 4 weeks relative to baseline. | The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). | baseline,at 4,8,12 weeks |
| Change in The Migraine-Specific Quality-of-Life Questionnaire, Version 2.1 (MSQ Version 2.1) score per 4 weeks relative to baseline. | The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines. | baseline,at 4,8,12 weeks |
| Patient Global Impression of Change (PGIC). | The PGIC is a single item questionnaire used to measure the participant's impression of overall change in migraine since the first dose of study medication. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse." | baseline,at 4,8,12 weeks |
| Change in The Patient Health Questionnaire-9 (PHQ-9) score per 4 weeks relative to baseline. | The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression. | baseline,at 4,8,12 weeks |
| Change in The General Anxiety Disorder-7(GAD-7) score per 4 weeks relative to baseline. | GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The GAD-7 scale score ranges from 0 to 21. | baseline,at 4,8,12 weeks |
| Change in The Functional Impairment Scale (FIS) score per 4 weeks relative to baseline. | Functional impairment scale (FIS) is a 4-point scale to evaluate the functional status and injury intensity in daily activities. It can be used in conjunction with the four-point pain intensity scale, usually done daily and summarized within four weeks. | baseline,at 4,8,12 weeks |
| Change in The European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) scores per 4 weeks relative to baseline. | EQ-5D-3L is a generic instrument for use as a measure of health status. The EQ-5D-3L consists of 2 components-the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state." The scoring range of the EQ VAS is from 0 (worst imaginable health) to 100 (best imaginable health). | baseline,at 4,8,12 weeks |
| Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) score per 4 weeks relative to baseline. | C-SSRS will be administered to study subjects at each study visit to assess possible suicidal ideation and behavior. Reports of suicidal ideation with intent to act (endorse item 4 or 5) and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide. | baseline,at 4,8,12 weeks |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |