Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis

December 20, 2015 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

62

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • sibelium
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 Names:
  • topamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)
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.
week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)
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.
week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)
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.
week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Shuu-Jiun Wang, M.D., Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-04-046B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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