MigrainePhase 2NCT01081795
A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine
A Phase 2 study testing Topiramate in people with Migraine, run by Janssen Pharmaceutical K.K. at 29 sites in Japan.
Trial summary
The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an… Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Migraine
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 29 sitesJapan
- Study dates
- Apr 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who meet the Second Edition of the International Classification of Headache Disorders (ICHD-II), 1.1 Migraine without aura or 1.2 Migraine with aura over at least 6 months before the time of informed consent
- Participants who had an average of no more than 8 migraine attacks per month during 3 months before informed consent and an average of no more than 14 headache (migraine and non-migraine) days
- Participants whose number of migraine attacks during the baseline determination period (28 days) is 3 to 12 according to the 24-hour rule and number of headache days (migraine and non-migraine) is no more than 14
- Participants who took no migraine preventive medications over 2 weeks before informed consent, or who can take at least 2-week washout period before baseline determination period if they are taking migraine preventive medications
- Female participants must be postmenopausal, surgically sterile, abstinent, or can take adequate contraceptive measures after informed consent and continue it to the completion of investigational treatment
Who cannot join
- Participants who cannot distinguish between migraine and non-migraine headache
- Participants with headache other than those described in the ICHD-II, 1.1 Migraine without aura, 1.2 Migraine with aura, 2. Tension headache or 11.5 Sinus headache
- If the participant has received drug therapies for prevention of migraine, the discontinued preventive therapies due to insufficient efficacy should be at least three types
- Participants who excessively took medications for migraine attacks such as analgesics (drug used to control pain) as medications to be taken as needed within 3 months before informed consent
- Participants who have taken topiramate (test drug in this study) in the past
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Study site
Bunkyō City
Study site
Chitose
Study site
Hachiōji
Study site
Iruma
Study site
Isehara
Study site
Kagoshima
Study site
Kamogawa
Study site
Kitakyushu
Study site
Kobe
Study site
Kumamoto
Study site
Kyoto
Study site
Minato
Study site
Morioka
Study site
Nagoya
Study site
Nishinomiya
Study site
Numakunai
Study site
Sagamihara
Study site
Sapporo
Study site
Shimotsuga
Study site
Shinjuku
Study site
Shinjuku-Ku
Study site
Shizuoka
Study site
Suginami-Ku
Study site
Tokyo
Study site
Toyama
Study site
Toyonaka
Study site
Ube
Study site
Yokohama
Study site
Yonago
About this study
Official title: A Placebo-Controlled Dose-Finding Study of JNS019 (Topiramate) in Migraine Patients
The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), and to assess if a same therapeutic effect can be observed between this study and overseas Caucasian clinical studies.
Read the detailed description
This study is a multicenter (more than 1 site), placebo-controlled (compared to placebo), randomized (participants assigned study drug by chance), double-blind (neither the participant nor the physician know the assigned study drug), parallel-group comparison (comparison for each group at the same time) study. The study period consists of 4 phases: the observation phase, double-blind phase, exit period and follow-up period. After the double-blind phase, the participants will be transferred to the continuous treatment study. The observation phase which is started after informed consent consists of the washout period (non-treatment period with migraine preventive medication: at least 2 weeks) and baseline determination period (at least 4 weeks). The participants who complete the observation phase and meet the inclusion criteria will be randomly assigned to the topiramate 50 milligram (mg) group, topiramate 100-mg group or placebo group after registration. The double-blind phase consists of the titration period (dose-escalation, 4 weeks) and fixed-dose period (18 weeks). In the titration period, starting from 1 topiramate 25-mg tablet or 1 topiramate 25-mg placebo tablet once daily (1 tablet in the evening), the dose will be increased by 1 tablet every week up to twice daily (2 tablets in the morning, 2 tablets in the evening). After that, the twice-daily treatment (2 tablets in the morning, 2 tablets in the evening) will be continued for 7 days from Day 22 to Day 28. In the fixed-dose period, the topiramate 25-mg tablets or topiramate 25-mg placebo tablets at the same dose as that in the final treatment in titration period will be continued. The participants who are not transferred to the continuous treatment study after completion of the double-blind phase or after discontinuation during the double-blind phase will be transferred to the exit period (up to 1 week).The participants who complete the exit period will be transferred to the follow-up period, and a follow-up of the participant's safety and headache symptoms such as the migraine period rate will be conducted for 4 weeks after the completion of investigational treatment. Meanwhile, the participants who complete the double-blind phase or those who discontinue the study at Week 4 or later in the fixed-dose period during the double-blind phase due to lack of efficacy and give consent to transfer to the continuous treatment study will be transferred to the transfer period (up to 3 weeks) under blind conditions.
- Conditions
- Migraine
- Being tested
- Topiramate, Placebo
- Keywords
- Topiramate, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
In the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).
PlaceboDrug
In the titration period, matching placebo tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).
| Study group | Role | What they receive |
|---|---|---|
| Topiramate (JNS019) 50 mg | Experimental | In titration period, topiramate 25 milligram (mg) tablet will be given once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period. Receives: Drug: Topiramate; Drug: Placebo |
| Topiramate 100 mg | Experimental | In titration period, topiramate 25 mg tablet will be given once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period. Receives: Drug: Topiramate |
| Placebo | Placebo comparator | In titration period, matching placebo tablet will be given once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice orally from Day 22 to Day 28 and will becontinued further for 18 weeks in the fixed dose period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) 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.
Measured: Baseline (28 days before randomization) through Month 6
Secondary outcomes (9)
Change From Baseline in Average Number of Monthly Migraine Attack Days at 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).
Measured: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
Change From Baseline in Average Number of Monthly Headache Days at 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).
Measured: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
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
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).
Measured: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at 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.
Measured: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over 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.
Measured: Baseline (28 days before randomization), Week 19 to Week 22 Period
Average Number of Rescue Drug Treatment Days
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).
Measured: Baseline (28 days before randomization)
Change From Baseline in the Average Number of Rescue Drug Treatment Days at 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).
Measured: Month 6
Percentage of Participants With Response to Study Treatment
Responders were the participants who had at least 50 percent reduction in the average number of monthly migraine attacks.
Measured: Month 1, 2, 3, 4, 5 and 6
Short Form-36 Health Survey (SF-36) Score
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.
Measured: Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startApr 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081795
- Sponsor's protocol ID
- CR013681
- Other IDs
- JNS019-JPN-02
- Status last verified
- Jun 2013
- First submitted
- 4 Mar 2010
- Last updated
- 2 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Dose-Finding Study of JNS019 (Topiramate) in Migraine Patients
- ClinicalTrials.gov ID
- NCT01081795
- Acronym / sponsor ID
- CR013681
- Conditions
- Migraine
- Keywords
- Topiramate, Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Posted 6 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), and to assess if a same therapeutic effect can be observed between this study and overseas Caucasian clinical studies.
Detailed description
This study is a multicenter (more than 1 site), placebo-controlled (compared to placebo), randomized (participants assigned study drug by chance), double-blind (neither the participant nor the physician know the assigned study drug), parallel-group comparison (comparison for each group at the same time) study. The study period consists of 4 phases: the observation phase, double-blind phase, exit period and follow-up period. After the double-blind phase, the participants will be transferred to the continuous treatment study. The observation phase which is started after informed consent consists of the washout period (non-treatment period with migraine preventive medication: at least 2 weeks) and baseline determination period (at least 4 weeks). The participants who complete the observation phase and meet the inclusion criteria will be randomly assigned to the topiramate 50 milligram (mg) group, topiramate 100-mg group or placebo group after registration. The double-blind phase consists of the titration period (dose-escalation, 4 weeks) and fixed-dose period (18 weeks). In the titration period, starting from 1 topiramate 25-mg tablet or 1 topiramate 25-mg placebo tablet once daily (1 tablet in the evening), the dose will be increased by 1 tablet every week up to twice daily (2 tablets in the morning, 2 tablets in the evening). After that, the twice-daily treatment (2 tablets in the morning, 2 tablets in the evening) will be continued for 7 days from Day 22 to Day 28. In the fixed-dose period, the topiramate 25-mg tablets or topiramate 25-mg placebo tablets at the same dose as that in the final treatment in titration period will be continued. The participants who are not transferred to the continuous treatment study after completion of the double-blind phase or after discontinuation during the double-blind phase will be transferred to the exit period (up to 1 week).The participants who complete the exit period will be transferred to the follow-up period, and a follow-up of the participant's safety and headache symptoms such as the migraine period rate will be conducted for 4 weeks after the completion of investigational treatment. Meanwhile, the participants who complete the double-blind phase or those who discontinue the study at Week 4 or later in the fixed-dose period during the double-blind phase due to lack of efficacy and give consent to transfer to the continuous treatment study will be transferred to the transfer period (up to 3 weeks) under blind conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topiramate (JNS019) 50 mg | Experimental | Drug: Topiramate, Drug: PlaceboIn titration period, topiramate 25 milligram (mg) tablet will be given once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period. |
| Topiramate 100 mg | Experimental | Drug: TopiramateIn titration period, topiramate 25 mg tablet will be given once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and will be continued further for 18 weeks in the fixed dose period. |
| Placebo | Placebo comparator | Drug: PlaceboIn titration period, matching placebo tablet will be given once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice orally from Day 22 to Day 28 and will becontinued further for 18 weeks in the fixed dose period. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who meet the Second Edition of the International Classification of Headache Disorders (ICHD-II), 1.1 Migraine without aura or 1.2 Migraine with aura over at least 6 months before the time of informed consent
- Participants who had an average of no more than 8 migraine attacks per month during 3 months before informed consent and an average of no more than 14 headache (migraine and non-migraine) days
- Participants whose number of migraine attacks during the baseline determination period (28 days) is 3 to 12 according to the 24-hour rule and number of headache days (migraine and non-migraine) is no more than 14
- Participants who took no migraine preventive medications over 2 weeks before informed consent, or who can take at least 2-week washout period before baseline determination period if they are taking migraine preventive medications
- Female participants must be postmenopausal, surgically sterile, abstinent, or can take adequate contraceptive measures after informed consent and continue it to the completion of investigational treatment
Key exclusion criteria (5 listed)
- Participants who cannot distinguish between migraine and non-migraine headache
- Participants with headache other than those described in the ICHD-II, 1.1 Migraine without aura, 1.2 Migraine with aura, 2. Tension headache or 11.5 Sinus headache
- If the participant has received drug therapies for prevention of migraine, the discontinued preventive therapies due to insufficient efficacy should be at least three types
- Participants who excessively took medications for migraine attacks such as analgesics (drug used to control pain) as medications to be taken as needed within 3 months before informed consent
- Participants who have taken topiramate (test drug in this study) in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopiramateIn the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period). | Drug | Topiramate (JNS019) 50 mg, Topiramate 100 mg |
| PlaceboIn the titration period, matching placebo tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period). | Drug | Placebo, Topiramate (JNS019) 50 mg |
Primary outcome
Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6
Time frame: 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.
9 secondary outcomes
Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6
Time frame: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6
Time frame: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
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
Time frame: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6
Time frame: Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6
Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period
Time frame: Baseline (28 days before randomization), Week 19 to Week 22 Period
Average Number of Rescue Drug Treatment Days
Time frame: Baseline (28 days before randomization)
Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6
Time frame: Month 6
Percentage of Participants With Response to Study Treatment
Time frame: Month 1, 2, 3, 4, 5 and 6
Short Form-36 Health Survey (SF-36) Score
Time frame: Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiramate in people with Migraine, run by Janssen Pharmaceutical K.K. at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6 (time frame: Baseline (28 days before randomization) through Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.