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Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639598
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Flunarizine Drug: Topiramate Phase 4

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Topiramate

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 Name: 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 Name: topamax




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Shuu-Jiun Wang, M.D. Taipei Veterans General Hospital, Taiwan
Publications of Results:

Other Publications:
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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
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
chronic migraine
prophylaxis
flunarizine
topiramate
Additional relevant MeSH terms:
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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