Clinical trial NCT01799590: Continuous Treatment Study of Topiramate in Migraine Participants
Official title: A Continuous Treatment Study of JNS019 (Topiramate) in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine
Topiramate
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 296
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to 28 days after last dose of study drug
Secondary outcomes:
measure: Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period
timeFrame: Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
measure: Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period
timeFrame: Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
measure: Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period
timeFrame: Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
measure: 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
timeFrame: Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
measure: Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period
timeFrame: Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
measure: Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period
timeFrame: Baseline (28 days before randomization) and Day 197 to Day 225
measure: Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period
timeFrame: Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)
measure: Percentage of Participants With Response to Treatment
timeFrame: Baseline (28 days before randomization) up to Day 225
measure: Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score
timeFrame: Baseline (28 days before randomization) and FE (Day 225/early discontinuation)
Other outcomes:
Locations:
city: Chitose
country: Japan
city: Hachioji
country: Japan
city: Isehara
country: Japan
city: Iwate
country: Japan
city: Kagoshima
country: Japan
city: Kamogawa
country: Japan
city: Kitakyushu
country: Japan
city: Kobe
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Minato
country: Japan
city: Morioka
country: Japan
city: Nagoya
country: Japan
city: Nishinomiya
country: Japan
city: Sagamihara N/A
country: Japan
city: Sapporo
country: Japan
city: Shinjuku-Ku
country: Japan
city: Shizuoka
country: Japan
city: Suginami-Ku
country: Japan
city: Tokyo
country: Japan
city: Toyama
country: Japan
city: Toyonaka
country: Japan
city: Ube
country: Japan
city: Yokohama
country: Japan
city: Yonago N/A
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: