Continuous Treatment Study of Topiramate in Migraine Participants

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 2

Conditions

Migraine

Treatments

Drug: Topiramate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01799590

CR013684

JNS019-JPN-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment

296 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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