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Continuous Treatment Study of Topiramate in Migraine Participants

NCT ID: NCT01799590

Last Updated: 2013-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting and constipation or diarrhea) who completed the JNS019-JPN-02 study.

Detailed Description

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This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than one center), dose-titration (dose escalation/reduction) study of topiramate in participants with migraine. This study is a continuous study for the participants who were enrolled in the JNS019-JPN-02 study. Participants who completed the JNS019-JPN-02 study will receive treatment for 52 weeks starting at Visit 4 of the JNS019-JPN-02 study. The present study will consist of 3 weeks of Transfer period (during this period the dose titration will take place and along with dose titration the new treatment will be initiated at 25 milligram per day \[25mg/day\]), Continuous treatment period (32 weeks), Exit period (up to 3 weeks) and Follow-up period (4 weeks). Participants in the Continuous treatment period will receive topiramate tablets orally in the dose range of 50 mg/day to 100 mg/day. Dose can be increased or decreased as per Investigator's discretion. The maximum daily dose will be 200 mg/day. Efficacy will be primarily evaluated by change from Baseline in the number of monthly migraine attacks in Continuous treatment period. Participants' safety will be monitored throughout the study.

Conditions

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Migraine

Keywords

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Migraine Topiramate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topiramate

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.

Interventions

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Topiramate

Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.

Intervention Type DRUG

Other Intervention Names

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JNS019

Eligibility Criteria

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Inclusion Criteria

\- Participants who completed the JNS019-JPN-02 study or discontinued the study at Week 4 or after in fixed-dose period because of insufficient efficacy

Exclusion Criteria

* Participants who discontinued the JNS019-JPN-02 study for an adverse event unrelated to the underlying disease
* Participants judged unfavorable to be transferred to this study because of the safety assessments in the JNS019-JPN-02 study
* Pregnant (carrying an unborn baby) female participants
* Other participants who were considered ineligible as per Investigator's discretion
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

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Chitose, , Japan

Site Status

Hachiōji, , Japan

Site Status

Isehara, , Japan

Site Status

Kagoshima, , Japan

Site Status

Kamogawa, , Japan

Site Status

Kitakyushu, , Japan

Site Status

Kobe, , Japan

Site Status

Kumamoto, , Japan

Site Status

Kyoto, , Japan

Site Status

Minato, , Japan

Site Status

Morioka, , Japan

Site Status

Nagoya, , Japan

Site Status

Nishinomiya, , Japan

Site Status

Numakunai, , Japan

Site Status

Sagamihara, , Japan

Site Status

Sapporo, , Japan

Site Status

Shinjuku-Ku, , Japan

Site Status

Shizuoka, , Japan

Site Status

Suginami-Ku, , Japan

Site Status

Tokyo, , Japan

Site Status

Toyama, , Japan

Site Status

Toyonaka, , Japan

Site Status

Ube, , Japan

Site Status

Yokohama, , Japan

Site Status

Yonago, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JNS019-JPN-03

Identifier Type: -

Identifier Source: secondary_id

CR013684

Identifier Type: -

Identifier Source: org_study_id