Idebenone for the Preventive Treatment of Migraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
Idebenone improves energy metabolism similarly to Coenzyme Q10, which is effective in migraine prophylaxis. The investigators compare idebenone (90 mg/day, 270 mg/day) and placebo in 180 migraine patients in a double-blind, randomized, placebo-controlled, multicenter trial to study whether Idebenone is superior to placebo in the prevention of episodic migraine with or without aura.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of episodic migraine.
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
Two to eight attacks per month, 5 days/month of interval headaches.
No over consumption of acute anti-migraine medication.
Disqualifiers
Clinical diagnosis of chronic migraine.
Subjects previously discontinued idebenone due to adverse events.
Subjects are taking idebenone or had taken idebenone within 14 days prior to enrollment.
Subjects with continuous headaches.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugPlacebo oral tablet, three times a day
90mg Idebenone
DrugIdebenone 30 MG Oral Tablet, three times a day
270mg Idebenone
DrugIdebenone 90 MG Oral Tablet, three times a day
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: 90mg IdebenoneExperimental treatment 2 interventions
Group B: 270mg IdebenoneExperimental treatment 2 interventions
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change of migraine attack frequency
The change of migraine attack frequency in month 4 compared with baseline. Headache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary. Degree of pain and results of treatment are scored by visual analogue scale(VAS).
Time frame
month 0, month 1, month 2, month 3, month 4Secondary outcomes
1
The change of days with headache
The change of days with headache per month compared with baseline. Headache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary.
Time frame
month 0, month 1, month 2, month 3, month 42
Mean severity of migraine
Mean severity of migraine per month compared with baselineHeadache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary. Degree of pain is scored by VAS.
Time frame
month 0, month 1, month 2, month 3, month 43
The change of days with nausea/vomiting
The change of days with nausea/vomiting per month compared with baselineHeadache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary.
Time frame
month 0, month 1, month 2, month 3, month 44
Mean duration of migraine
Mean duration of migraine per month compared with baselineHeadache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary.
Time frame
month 0, month 1, month 2, month 3, month 4Sponsors and contacts
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Source ClinicalTrials.gov