Continuous Treatment Study of Topiramate in Migraine Participants
Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Topiramate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Janssen Pharmaceutical K.K. Official(s) and/or principal investigator(s): Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.
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.
Clinical Details
Official title: A Continuous Treatment Study of JNS019 (Topiramate) in Migraine Patients
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Adverse Events
Secondary outcome: Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment PeriodChange From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period Percentage of Participants With Response to Treatment Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score
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 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Chitose, Japan
Hachioji, Japan
Isehara, Japan
Iwate, Japan
Kagoshima, Japan
Kamogawa, Japan
Kitakyushu, Japan
Kobe, Japan
Kumamoto, Japan
Kyoto, Japan
Minato, Japan
Morioka, Japan
Nagoya, Japan
Nishinomiya, Japan
Sagamihara N/A, Japan
Sapporo, Japan
Shinjuku-Ku, Japan
Shizuoka, Japan
Suginami-Ku, Japan
Tokyo, Japan
Toyama, Japan
Toyonaka, Japan
Ube, Japan
Yokohama, Japan
Yonago N/A, Japan
Additional Information
Starting date: August 2007
Last updated: May 24, 2013
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