Trial · NCT01799590
Continuous Treatment Study of Topiramate in Migraine Participants
NCT01799590, 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. Continuous Treatment Study of Topiramate in Migraine Participants. Trials, record NCT01799590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01799590
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous Treatment Study of Topiramate in Migraine Participants
- NCT number
- NCT01799590
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 296 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Migraine
- Interventions
- Topiramate
- First posted
- 2013-02-27
- Last updated
- 2013-05-31
- 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 | Number of Participants With Adverse Events | Baseline up to 28 days after last dose of study drug | 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. |
| Secondary | 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) | As per 24-hour rule, if symptom of pain because of 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 interval between the latest migraine attack (ending time) and previous migraine attack (onset time) was less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started. |
| Secondary | 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) | Migraine:disabling headache disorder;2 major subtypes:migraine without aura(at least 5 attacks for 4-72 hours with at least 2 characteristics: unilateral location,pulsating quality,moderate/severe pain intensity or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia,phonophobia);migraine with aura(attack with reversible focal neurological symptoms that develop over 5-20 minutes, last for less than 60 minutes);average=total number of migraine attack days divided by total number of days of assessment and multiplied by 28,where a month=28 days. |
| Secondary | 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) | Migraine headache day was defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Average was calculated as total number of monthly headache days divided by total number of days of assessment and multiplied by 28, where a month was considered to last 28 days. |
| 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 | Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225) | Migraine has 2 major subtypes: migraine without aura (minimum 5 attacks of headache lasting for 4-72 hours, has 2 of these characteristics \[unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity\] and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (2 attacks of headache with typical aura with migraine headache or typical aura with non-migraine headache or typical aura without headache or familial hemiplegic migraine or sporadic hemiplegic migraine or basilar-type migraine). |
| Secondary | 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) | As per 48-hour rule, if the symptom of pain because of 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, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started. |
| 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 | Baseline (28 days before randomization) and Day 197 to Day 225 | As per 24-hour rule, if symptom of pain because of 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 interval between the latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started. |
| Secondary | Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period | Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225) | If aura of migraine, migraine attack or non-migraine headache attack occurred in study, these rescue drugs were permitted:analgesics, non-steroidal anti-inflammatory drugs (NSAIDs),ergotamines,triptans,antiemetics. Drugs with restricted treatment days of less than (\<) 15 days per month (28 days):analgesics, NSAIDs,combination of rescue drugs and those with \<10 days per month:triptans,ergotamines, opioids,combination analgesics. Average calculated as total number of monthly rescue-drug treatment days divided by the total number of days of assessment and multiplied by 28, where a month = 28 days. |
| Secondary | Percentage of Participants With Response to Treatment | Baseline (28 days before randomization) up to Day 225 | Responders were defined as participants who had a 50 percent or more reduction in frequency of migraine attacks. Migraine is common disabling headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 characteristics: unilateral location, pulsating quality, moderate/severe pain or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (attack with reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes). |
| Secondary | Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score | Baseline (28 days before randomization) and FE (Day 225/early discontinuation) | The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Final evaluation (FE) was done at Day 225 or at discontinuation. |
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 | Number of Participants With Adverse Events | Baseline up to 28 days after last dose of study drug | Safety population included all participants who received at least 1 dose of study medication. | Participants | NUMBER |
| SECONDARY | 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) | 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 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) | 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 Monthly Headache Days in Continuous Treatment Period | Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225) | 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 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) | 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 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) | 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 the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period | Baseline (28 days before randomization) and Day 197 to Day 225 | 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 the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period | Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225) | 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 | Percentage of Participants With Response to Treatment | Baseline (28 days before randomization) up to Day 225 | 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 | Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score | Baseline (28 days before randomization) and FE (Day 225/early discontinuation) | 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 group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Placebo/Topiramate (JNS019) | 110 | Participants | ||
| Number of Participants With Adverse Events | Topiramate (JNS019) 50 mg | 85 | Participants | ||
| Number of Participants With Adverse Events | Topiramate (JNS019) 100 mg | 79 | Participants | ||
| Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period | Placebo/Topiramate (JNS019) | Baseline (28 days before randomization) | 6.5 | Standard Deviation 2.27 | Migraine attacks |
| Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period | Topiramate (JNS019) 50 mg | Baseline (28 days before randomization) | 5.9 | Standard Deviation 1.76 | Migraine attacks |
| Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period | Topiramate (JNS019) 100 mg | Baseline (28 days before randomization) | 6.0 | Standard Deviation 1.91 | Migraine attacks |
| Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period | Placebo/Topiramate (JNS019) | Change during Continuous treatment period | -2.1 | Standard Deviation 2.47 | Migraine attacks |
| Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period | Topiramate (JNS019) 50 mg | Change during Continuous treatment period | -1.0 | Standard Deviation 3.21 | Migraine attacks |
| Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period | Topiramate (JNS019) 100 mg | Change during Continuous treatment period | -1.6 | Standard Deviation 2.11 | Migraine attacks |
| Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period | Placebo/Topiramate (JNS019) | Baseline (28 days before randomization) | 7.3 | Standard Deviation 2.56 | Days |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Topiramate (JNS019) | 111 | |
| Overall Study | STARTED | Topiramate (JNS019) 50 mg | 94 | |
| Overall Study | STARTED | Topiramate (JNS019) 100 mg | 91 | |
| Overall Study | COMPLETED | Placebo/Topiramate (JNS019) | 85 | |
| Overall Study | COMPLETED | Topiramate (JNS019) 50 mg | 78 | |
| Overall Study | COMPLETED | Topiramate (JNS019) 100 mg | 77 | |
| Overall Study | NOT COMPLETED | Placebo/Topiramate (JNS019) | 26 | |
| Overall Study | NOT COMPLETED | Topiramate (JNS019) 50 mg | 16 | |
| Overall Study | NOT COMPLETED | Topiramate (JNS019) 100 mg | 14 |
Source ClinicalTrials.gov
Adverse events93
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 | Placebo/Topiramate (JNS019) | 39 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Topiramate (JNS019) 50 mg | 36 | 94 | |
| other | Nasopharyngitis | Infections and infestations | Topiramate (JNS019) 100 mg | 36 | 91 | |
| other | Gastroenteritis | Infections and infestations | Placebo/Topiramate (JNS019) | 8 | 111 | |
| other | Gastroenteritis | Infections and infestations | Topiramate (JNS019) 50 mg | 5 | 94 | |
| other | Gastroenteritis | Infections and infestations | Topiramate (JNS019) 100 mg | 4 | 91 | |
| other | Cystitis | Infections and infestations | Placebo/Topiramate (JNS019) | 6 | 111 | |
| other | Cystitis | Infections and infestations | Topiramate (JNS019) 50 mg | 3 | 94 | |
| other | Cystitis | Infections and infestations | Topiramate (JNS019) 100 mg | 3 | 91 | |
| other | Influenza | Infections and infestations | Placebo/Topiramate (JNS019) | 2 | 111 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/Topiramate (JNS019) | ||
| Total, all-cause mortality | Topiramate (JNS019) 50 mg | ||
| Total, all-cause mortality | Topiramate (JNS019) 100 mg | ||
| Total, other adverse events | Placebo/Topiramate (JNS019) | 110 | 111 |
| Total, other adverse events | Topiramate (JNS019) 50 mg | 85 | 94 |
| Total, other adverse events | Topiramate (JNS019) 100 mg | 79 | 91 |
| Total, serious adverse events | Placebo/Topiramate (JNS019) | 3 | 111 |
| Total, serious adverse events | Topiramate (JNS019) 50 mg | 0 | 94 |
| Total, serious adverse events | Topiramate (JNS019) 100 mg | 2 | 91 |
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/NCT01799590
GET https://conductscience.org/api/trials/v1/NCT01799590/results?page=2