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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 Period

Change 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

Page last updated: August 23, 2015

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