A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine

NCT01081795 | Completed Phase 2 Results

• 2 other identifiers: CR013681JNS019-JPN-02
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 29

Brief Summary

The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), and to assess if a same therapeutic effect can be observed between this study and overseas Caucasian clinical studies.

Conditions

Migraine

Keywords

Topiramate; Migraine

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6

  As per 24-hour rule, if symptom of pain due to migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If the interval between latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks should be considered as 1 migraine attack. If the onset of migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if aura had started. Mean change was calculated by subtracting baseline value from the mean of 6 months value.

  Baseline (28 days before randomization) through Month 6

Secondary Outcomes (9)

• Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6

  Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6

• Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6

  Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6

• Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6

  Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6

• Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6

  Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6

• Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period

  Baseline (28 days before randomization), Week 19 to Week 22 Period

Study Arms (3)

Topiramate (JNS019) 50 mg

EXPERIMENTAL

In titration period, topiramate 25 milligram (mg) tablet will be given once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period.

Drug: Topiramate; Drug: Placebo

Topiramate 100 mg

EXPERIMENTAL

In titration period, topiramate 25 mg tablet will be given once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period.

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

In titration period, matching placebo tablet will be given once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice orally from Day 22 to Day 28 and will becontinued further for 18 weeks in the fixed dose period.

Drug: Placebo

Interventions

Topiramate DRUG

In the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).

Topiramate (JNS019) 50 mg; Topiramate 100 mg

Placebo DRUG

In the titration period, matching placebo tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).

Placebo; Topiramate (JNS019) 50 mg

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who meet the Second Edition of the International Classification of Headache Disorders (ICHD-II), 1.1 Migraine without aura or 1.2 Migraine with aura over at least 6 months before the time of informed consent
• Participants who had an average of no more than 8 migraine attacks per month during 3 months before informed consent and an average of no more than 14 headache (migraine and non-migraine) days
• Participants whose number of migraine attacks during the baseline determination period (28 days) is 3 to 12 according to the 24-hour rule and number of headache days (migraine and non-migraine) is no more than 14
• Participants who took no migraine preventive medications over 2 weeks before informed consent, or who can take at least 2-week washout period before baseline determination period if they are taking migraine preventive medications
• Female participants must be postmenopausal, surgically sterile, abstinent, or can take adequate contraceptive measures after informed consent and continue it to the completion of investigational treatment

You may not qualify if:

• Participants who cannot distinguish between migraine and non-migraine headache
• Participants with headache other than those described in the ICHD-II, 1.1 Migraine without aura, 1.2 Migraine with aura, 2. Tension headache or 11.5 Sinus headache
• If the participant has received drug therapies for prevention of migraine, the discontinued preventive therapies due to insufficient efficacy should be at least three types
• Participants who excessively took medications for migraine attacks such as analgesics (drug used to control pain) as medications to be taken as needed within 3 months before informed consent
• Participants who have taken topiramate (test drug in this study) in the past

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (29)

Unknown Facility

Bunkyō City, Japan

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Chitose, Japan

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Hachiōji, Japan

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Iruma, Japan

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Isehara, Japan

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Kagoshima, Japan

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Kamogawa, Japan

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Kitakyushu, Japan

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Kobe, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Minato, Japan

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Morioka, Japan

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Nagoya, Japan

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Nishinomiya, Japan

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Numakunai, Japan

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Sagamihara, Japan

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Sapporo, Japan

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Shimotsuga, Japan

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Shinjuku, Japan

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Shinjuku-Ku, Japan

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Shizuoka, Japan

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Suginami-Ku, Japan

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Tokyo, Japan

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Toyama, Japan

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Toyonaka, Japan

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Ube, Japan

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Yokohama, Japan

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Yonago, Japan

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MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Group Manager
• Organization: Janssen Pharmaceutical KK Japan

+81-3-4411-5072

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: April 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 2, 2013
• Results First Posted: May 6, 2013

Record last verified: 2013-06

Locations

JP (29)