An Efficacy and Tolerability Study of Topiramate in Participants With Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01060111
First received: January 29, 2010
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to investigate the adequacy (reasonably good) of topiramate therapy (medicine or medical care given to a participant for a disease or condition) in prevention of migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea) by comparing standard titration (slow increase in drug dosage, guided by patient's responses) therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol in participants with migraine with or without aura (having to do with the ear) for more than or equal to 2 attacks per month.


Condition Intervention Phase
Migraine
Drug: Topiramate Standard
Drug: Topiramate Slow
Drug: Propranolol booster
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Adequate Therapy of Topiramate in Migraine

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Percentage Decrease in Migraine Episodes [ Time Frame: Maintenance period (Weeks 7 to 10) ] [ Designated as safety issue: No ]
    Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS).


Secondary Outcome Measures:
  • Change From Baseline in Migraine Frequency at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6.

  • Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6.

  • Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating "no headache" and the other end with 10 points indicating "unimaginably strong headache." It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6.


Enrollment: 250
Study Start Date: July 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate Standard
Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
Drug: Topiramate Standard
Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
Experimental: Topiramate Slow
Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
Drug: Topiramate Slow
Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
Experimental: Topiramate Slow and Propranolol Booster
Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
Drug: Topiramate Slow
Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
Drug: Propranolol booster
Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.

Detailed Description:

This is a prospective (study following participants forward in time), single-blind (Physician does not know the intervention), randomized (study drug assigned by chance) and comparative multi-center (conducted in more than 1 center) study to assess appropriate administration methods with topiramate preventive therapy in participants with migraine. The study consists of 3 periods: Screening period (4 weeks), Treatment period consisting of 2 titration periods (3 weeks each) and Maintenance period (4 weeks). During Screening period, after the diagnosis of participants' headache, symptoms and severity of migraine will be investigated through a headache diary and participants will be selected for treatment period. In the treatment period, the selected participants will be randomly assigned to either of the 3 topiramate therapy: 'topiramate standard group', 'topiramate slow group', and 'topiramate slow plus propranolol (booster) group'. In the 'topiramate standard group' - participants will receive an initial dose of topiramate 25 milligram (mg) once daily and the dose of topiramate will be increased by 25 mg per day at an interval of 1-week up to the target dose of 50 mg to 100 mg up to Week 6; and a maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. In 'topiramate slow group' - participants will start with an initial dose of 25 mg once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. In 'topiramate slow plus propranolol (booster) group' - participants will follow the same dosage regimen as in the 'topiramate slow group' along with concurrent administration of booster dose of propranolol 80 mg once daily (40 mg each time in the morning and in the evening) for 6 weeks. The participants will primarily be evaluated for reduction in migraine frequency between Week 7 and 10 using a headache diary questionnaire maintained by them. Participants' quality of life will be assessed using Migraine Disability Assessment (MIDAS) score and intensity of pain in migraine will be assessed using Visual Analogue Scale (VAS). Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Particpants who have signed the consent form
  • Participants who have 3 to 14 episodes of migraine a month
  • Participants whose duration of migraine is at least 6 months
  • Participants who can read and understand the migraine disability assessment (MIDAS) questionnaire
  • Female Participants who are using an appropriate contraception method or have negative pregnancy test results

Exclusion Criteria:

  • Participants whose headache attacks at Baseline or during the study period are assumed to be caused by a drug withdrawal syndrome
  • Participants whose migraine has appeared first at over 50 years of age
  • Participants who have taken anticonvulsants (valproic acid, gabapentin), beta adrenergic blockers (propranolol) and calcium antagonists (sibelium, verapamil, diltiazem) or topiramate or propranolol within the last 8 weeks
  • Participants with progressive neurological (pertaining to the nervous system) disorder
  • Participants with severe renal (pertaining to the kidneys) disorder, hepatic (pertaining to the liver) failure or diabetes (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects) or with the history of renal calculus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060111

Locations
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Kwangjoo, Korea, Republic of
Kyunggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Uijeongbu, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060111     History of Changes
Other Study ID Numbers: CR011944, MIG-KOR-001
Study First Received: January 29, 2010
Results First Received: March 26, 2013
Last Updated: August 14, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Migraine
Topiramate
Propranolol

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Propranolol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 29, 2014