Overview

Continuous Treatment Study of Topiramate in Migraine Participants

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
Treatments:
Topiramate
Criteria
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