Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis
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| ClinicalTrials.gov Identifier: NCT02639598 |
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Recruitment Status :
Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Migraine | Drug: Flunarizine Drug: Topiramate | Phase 4 |
Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as compared with 50 mg/day topiramate.
We conducted a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Patients with CM were randomized (1:1) to flunarizine and topiramate treatment groups.
This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4).
The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 25 mg/day topiramate or 5 mg/day flunarizine once daily in the first week, followed by 50 mg/day topiramate or 10 mg/day flunarizine in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4.
Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected and directed to the outcome evaluators, who were blinded to the patients' treatment.
The primary outcomes assessed were the reductions in the total numbers of headache days and migraine days after 8 weeks of treatment (weeks 7 to 8 vs. weeks -2 to 0). Secondary outcomes were reductions in the numbers of days of acute abortive medication intake and acute abortive medication tablets taken, and the 50% responder rate.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis |
| Study Start Date : | June 2012 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | March 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: flunarizine
This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4). The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 5 mg/day flunarizine once daily in the first week, followed by 10 mg/day flunarizine in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4. |
Drug: Flunarizine
as in "arm descriptions"
Other Name: sibelium |
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Active Comparator: topiramate
This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4). The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 25 mg/day topiramate once daily in the first week, followed by 50 mg/day topiramate in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4. |
Drug: Topiramate
as in "arm descriptions"
Other Name: topamax |
- reduction of total number of headache days (by diary log) [ Time Frame: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0) ]Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
- reduction of number of migraine days (by diary log) [ Time Frame: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0) ]Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
- reduction of number of days of acute abortive medication intake (by diary log) [ Time Frame: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0) ]Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
- reduction of number of acute abortive medication tablets taken (by diary log) [ Time Frame: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0) ]Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
- fifty percent responder rate (by diary log) [ Time Frame: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0) ]Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ICHD-IIR criteria for CM (as reported by the patient)
- Experienced ≥7 days of headache lasting ≥30 min during T0 (-2 week to 0 week).
- On ≥4 of these days, subjects were required to have experienced migrainous headache
- Prophylaxis-naïve (i.e., patients could not receive any preventive medications)
- With and without medication overuse
Exclusion Criteria:
- Headache type other than CM
- Migraine onset after the age of 50 years
- CM onset after the age of 60 years
- Previous history of migraine prophylaxis before enrollment
- Pregnancy or nursing status
- History of hepatic or renal disorder, nephrolithiasis or other severe systemic disease
- Severe depression (BDI score ≥ 30 at visit 1)
- Conditions incompatible with MRI, such as claustrophobia or metallic or electric implants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639598
| Principal Investigator: | Shuu-Jiun Wang, M.D. | Taipei Veterans General Hospital, Taiwan |
Other Publications:
| Responsible Party: | vghtpe user, Deputy Head, Neurological Institute, Taipei Veterans General Hospital, Taiwan |
| ClinicalTrials.gov Identifier: | NCT02639598 |
| Other Study ID Numbers: |
2012-04-046B |
| First Posted: | December 24, 2015 Key Record Dates |
| Last Update Posted: | December 24, 2015 |
| Last Verified: | December 2015 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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chronic migraine prophylaxis flunarizine topiramate |
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Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Topiramate Flunarizine Anticonvulsants Hypoglycemic Agents |
Physiological Effects of Drugs Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Vasodilator Agents |