Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients

NCT05411978 | Unknown Phase 4 DMC

• 1 other identifier: ADBK-3101-303-002
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine Prophylaxis; Mitochondrial Dysfunction; Idebenone Individualized Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• Frequency of headache attacks per 4 weeks as compared to baseline.

  baseline,at 4,8,12 weeks

• Changes in the moderate / severe headache days per 4 weeks relative to the baseline

  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.

  baseline,at 4,8,12 weeks

• Change in frequency of acute drug use per 4 weeks relative to baseline.

  baseline,at 4,8,12 weeks

• Change in dose of acute drug use per 4 weeks relative to baseline.

  baseline,at 4,8,12 weeks

Study Arms (3)

Idebenone 30 mg+ Placebo 60 mg

PLACEBO COMPARATOR

Idebenone 30 mg+ placebo 60 mg TID Oral ,for 12 weeks

Drug: Idebenone+ placebo

Idebenone 90 mg

EXPERIMENTAL

Idebenone 90 mg TID Oral ,for 12 weeks

Drug: Idebenone

Placebo 90 mg

PLACEBO COMPARATOR

Placebo 90 mg TID Oral,for 12 weeks

Drug: Placebo

Interventions

Idebenone+ placebo DRUG

Participants will receive Idebenone 30 mg+ placebo 60 mg for 12 weeks.

Also known as: Idebenone 30 mg+ placebo 60 mg

Idebenone 30 mg+ Placebo 60 mg

Idebenone DRUG

Participants will receive Idebenone 90 mg for 12 weeks.

Also known as: Idebenone 90 mg

Idebenone 90 mg

Placebo DRUG

Participants will receive Placebo 90 mg for 12 weeks

Also known as: Placebo 90 mg

Placebo 90 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Yonggang Wang

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Mitochondrial Diseases

Interventions

idebenone

Condition Hierarchy (Ancestors)

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

Central Study Contacts

YONGGANG WANG

CONTACT

15010066622; w100yg@163.com

YAQING ZHANG

CONTACT

13910760399; Zhyq0401@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 9, 2022
• Study Start: May 9, 2022
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

CN (1)