An Efficacy and Tolerability Study of Topiramate in Participants With Migraine

NCT01060111 | Completed Phase 4 Results

• 2 other identifiers: CR011944MIG-KOR-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine; Topiramate; Propranolol

Outcome Measures

Primary Outcomes (1)

• Percentage Decrease in Migraine Episodes

  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).

  Maintenance period (Weeks 7 to 10)

Secondary Outcomes (3)

• Change From Baseline in Migraine Frequency at Week 6

  Baseline and Week 6

• Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6

  Baseline and Week 6

• Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6

  Baseline and Week 6

Study Arms (3)

Topiramate Standard

EXPERIMENTAL

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 Slow

EXPERIMENTAL

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 Slow and Propranolol Booster

EXPERIMENTAL

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; Drug: Propranolol booster

Interventions

Topiramate Standard DRUG

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.

Topiramate Standard

Topiramate Slow DRUG

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.

Topiramate Slow; Topiramate Slow and Propranolol Booster

Propranolol booster DRUG

Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.

Topiramate Slow and Propranolol Booster

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (6)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Kwangjoo, South Korea

Location

Unknown Facility

Kyunggi-Do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Uijeongbu-si, South Korea

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Medical Affairs / Janssen-Cil Korea

82-2-2094-4837

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 2, 2010
• Study Start: July 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 22, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-08

Locations

KR (6)