Phase 2
N=296
Continuous Treatment Study of Topiramate in Migraine Participants
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT01799590 ↗Enrolled (actual)
296
Serious AEs
1.7%
Results posted
May 2013
Primary outcome: Primary: Number of Participants With Adverse Events — 110; 85; 79 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Topiramate (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
110; 85; 79 | — |
| SECONDARY Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period |
6.5; 5.9; 6.0; -2.1; -1.0; -1.6 | — |
| SECONDARY Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period |
7.3; 6.5; 6.7; -2.4; -1.1; -1.9 | — |
| SECONDARY Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period |
7.5; 6.8; 7.2; -2.6; -1.2; -2.1 | — |
| SECONDARY 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 |
4.7; 4.6; 4.6; -1.9; -1.6; -1.6 | — |
| SECONDARY Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period |
5.0; 4.6; 4.8; -1.6; -0.9; -1.3 | — |
| SECONDARY Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period |
6.5; 5.9; 6.0; -1.9; -1.1; -1.4 | — |
| SECONDARY Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period |
5.9; 5.5; 5.2; -1.6; -0.7; -1.0 | — |
| SECONDARY Percentage of Participants With Response to Treatment |
36.0; 18.1; 22.0 | — |
| SECONDARY Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score |
54.06; 53.52; 54.10; 53.14; 54.35; 54.79 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01799590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.