Trial · NCT01081795
A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine
NCT01081795, Phase 2, Completed, Janssen Pharmaceutical K.K.; results first posted 2013-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine. Trials, record NCT01081795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01081795
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine
- NCT number
- NCT01081795
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 387 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Migraine
- Interventions
- Topiramate, Placebo
- First posted
- 2010-03-05
- Last updated
- 2013-07-02
- Results first posted
- 2013-05-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Baseline (28 days before randomization) through Month 6 | As per 24-hour rule, if symptom of pain due to migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If the interval between latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks should be considered as 1 migraine attack. If the onset of migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if aura had started. Mean change was calculated by subtracting baseline value from the mean of 6 months value. |
| Secondary | Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attack days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days). |
| Secondary | Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | Headache days were the days when at least 30-minute migraine and non-migraine headache occurred and were calculated from the headache diaries kept by the participants. Average at given month was calculated by dividing total number of headache days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days). |
| Secondary | Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attacks until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days). |
| Secondary | Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | As per 48-hour rule, if the symptom of pain due to migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, the 2 migraine attacks should be considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if the aura had started. |
| Secondary | Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period | Baseline (28 days before randomization), Week 19 to Week 22 Period | The change from baseline in average number of migraine attacks (as per 24-hour rule) over Week 19 to Week 22 period was calculated by subtracting the baseline value from the average value of the Week 19 to Week 22 period. |
| Secondary | Average Number of Rescue Drug Treatment Days | Baseline (28 days before randomization) | Rescue medications are administered to participants when efficacy of study drug is not satisfactory, or effect of study drug is too great and is likely to cause a hazard to participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), ergotamines, triptans and anti-emetics (drug used to stop vomiting). Average at baseline was calculated by dividing total number of rescue drug treatment days until baseline by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days). |
| Secondary | Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6 | Month 6 | Rescue medications are medicines that may be administered to the participants when efficacy of study drug is not satisfactory, or the effect of study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, NSAIDs, ergotamines, triptans and anti-emetics. Average at Month 6 was calculated by dividing total number of rescue drug treatment days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days). |
| Secondary | Percentage of Participants With Response to Study Treatment | Month 1, 2, 3, 4, 5 and 6 | Responders were the participants who had at least 50 percent reduction in the average number of monthly migraine attacks. |
| Secondary | Short Form-36 Health Survey (SF-36) Score | Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW]) | The SF-36 is a survey of participant health. It consists of 8 scaled scores, which are weighted sums of the questions in their section. The 8 sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each item is scored on a 0-100 range so that total score ranges from 0-100 with high score indicating more favorable health state. Final evaluation was done at Day 155 or at discontinuation for those participants who discontinued before Day 155. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Baseline (28 days before randomization) through Month 6 | Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Migraine attacks | MEAN |
| SECONDARY | Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Days | MEAN |
| SECONDARY | Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Days | MEAN |
| SECONDARY | Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Migraine attacks | MEAN |
| SECONDARY | Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6 | Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6 | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Migraine attacks | MEAN |
| SECONDARY | Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period | Baseline (28 days before randomization), Week 19 to Week 22 Period | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Migraine attacks | LEAST_SQUARES_MEAN |
| SECONDARY | Average Number of Rescue Drug Treatment Days | Baseline (28 days before randomization) | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Days | MEAN |
| SECONDARY | Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6 | Month 6 | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Response to Study Treatment | Month 1, 2, 3, 4, 5 and 6 | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. | Percentage of participants | NUMBER |
| SECONDARY | Short Form-36 Health Survey (SF-36) Score | Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW]) | The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here 'n' signifies those participants who were evaluable for this measure at given time points. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group213
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Topiramate (JNS019) 50 mg | Baseline | 5.9 | Standard Deviation 1.79 | Migraine attacks |
| Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Topiramate 100 mg | Baseline | 6.2 | Standard Deviation 2.11 | Migraine attacks |
| Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Placebo | Baseline | 6.6 | Standard Deviation 2.29 | Migraine attacks |
| Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Topiramate (JNS019) 50 mg | Change at Month 6 | -0.9 | Standard Deviation 2.50 | Migraine attacks |
| Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Topiramate 100 mg | Change at Month 6 | -1.2 | Standard Deviation 2.72 | Migraine attacks |
| Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 | Placebo | Change at Month 6 | -1.0 | Standard Deviation 2.42 | Migraine attacks |
| Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6 | Topiramate (JNS019) 50 mg | Baseline | 6.6 | Standard Deviation 2.21 | Days |
| Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6 | Topiramate 100 mg | Baseline | 7.0 | Standard Deviation 2.35 | Days |
| Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6 | Placebo | Baseline | 7.3 | Standard Deviation 2.58 | Days |
| Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6 | Topiramate (JNS019) 50 mg | Change at Month 1 | -0.5 | Standard Deviation 2.93 | Days |
1 to 10 of 213Source ClinicalTrials.gov
See all 213 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate (JNS019) 50 mg | 130 | |
| Overall Study | STARTED | Topiramate 100 mg | 130 | |
| Overall Study | STARTED | Placebo | 127 | |
| Overall Study | COMPLETED | Topiramate (JNS019) 50 mg | 97 | |
| Overall Study | COMPLETED | Topiramate 100 mg | 95 | |
| Overall Study | COMPLETED | Placebo | 97 | |
| Overall Study | NOT COMPLETED | Topiramate (JNS019) 50 mg | 33 | |
| Overall Study | NOT COMPLETED | Topiramate 100 mg | 35 | |
| Overall Study | NOT COMPLETED | Placebo | 30 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Topiramate (JNS019) 50 mg | 45 | 130 | |
| other | Nasopharyngitis | Infections and infestations | Topiramate 100 mg | 39 | 130 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 37 | 127 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Topiramate (JNS019) 50 mg | 8 | 130 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Topiramate 100 mg | 11 | 130 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 3 | 127 | |
| other | Paraesthesia | Nervous system disorders | Topiramate (JNS019) 50 mg | 38 | 130 | |
| other | Paraesthesia | Nervous system disorders | Topiramate 100 mg | 50 | 130 | |
| other | Paraesthesia | Nervous system disorders | Placebo | 4 | 127 | |
| other | Dysaesthesia | Nervous system disorders | Topiramate (JNS019) 50 mg | 35 | 130 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate (JNS019) 50 mg | ||
| Total, all-cause mortality | Topiramate 100 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Topiramate (JNS019) 50 mg | 125 | 130 |
| Total, other adverse events | Topiramate 100 mg | 121 | 130 |
| Total, other adverse events | Placebo | 106 | 127 |
| Total, serious adverse events | Topiramate (JNS019) 50 mg | 2 | 130 |
| Total, serious adverse events | Topiramate 100 mg | 4 | 130 |
| Total, serious adverse events | Placebo | 2 | 127 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01081795
GET https://conductscience.org/api/trials/v1/NCT01081795/results?page=2