Status:
COMPLETED
Continuous Treatment Study of Topiramate in Migraine Participants
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Migraine
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief 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, vomi...
Detailed 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 participant...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01799590
Start Date
August 1 2007
End Date
November 1 2009
Last Update
May 31 2013
Active Locations (25)
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1
Chitose, Japan
2
Hachiōji, Japan
3
Isehara, Japan
4
Kagoshima, Japan