Continuous Treatment Study of Topiramate in Migraine Participants
A Continuous Treatment Study of JNS019 (Topiramate) in Migraine Patients
2 other identifiers
interventional
296
1 country
25
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, vomiting and constipation or diarrhea) who completed the JNS019-JPN-02 study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
February 27, 2013
CompletedResults Posted
Study results publicly available
May 6, 2013
CompletedMay 31, 2013
May 1, 2013
2.3 years
February 25, 2013
March 19, 2013
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Baseline up to 28 days after last dose of study drug
Secondary Outcomes (9)
Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period
Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period
Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period
Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
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
Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period
Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
- +4 more secondary outcomes
Study Arms (1)
Topiramate
EXPERIMENTALInterventions
Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Chitose, Japan
Unknown Facility
Hachiōji, Japan
Unknown Facility
Isehara, Japan
Unknown Facility
Kagoshima, Japan
Unknown Facility
Kamogawa, Japan
Unknown Facility
Kitakyushu, Japan
Unknown Facility
Kobe, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Minato, Japan
Unknown Facility
Morioka, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Nishinomiya, Japan
Unknown Facility
Numakunai, Japan
Unknown Facility
Sagamihara, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Shinjuku-Ku, Japan
Unknown Facility
Shizuoka, Japan
Unknown Facility
Suginami-Ku, Japan
Unknown Facility
Tokyo, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Toyonaka, Japan
Unknown Facility
Ube, Japan
Unknown Facility
Yokohama, Japan
Unknown Facility
Yonago, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Group Manager
- Organization
- Janssen Pharmaceutical KK Japan
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
February 27, 2013
Study Start
August 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
May 31, 2013
Results First Posted
May 6, 2013
Record last verified: 2013-05