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Continuous Treatment Study of Topiramate in Migraine Participants

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ClinicalTrials.gov Identifier: NCT01799590
Recruitment Status : Completed
First Posted : February 27, 2013
Results First Posted : May 6, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Topiramate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continuous Treatment Study of JNS019 (Topiramate) in Migraine Patients
Study Start Date : August 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: Topiramate Drug: Topiramate
Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.
Other Name: JNS019




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 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 Outcome Measures :
  1. Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period [ Time Frame: 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.

  2. Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period [ Time Frame: 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.

  3. Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period [ Time Frame: 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.

  4. 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 [ Time Frame: 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).

  5. Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period [ Time Frame: 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.

  6. Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period [ Time Frame: 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.

  7. Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period [ Time Frame: 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.

  8. Percentage of Participants With Response to Treatment [ Time Frame: 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).

  9. Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799590


Locations
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Japan
Chitose, Japan
Hachioji, Japan
Isehara, Japan
Iwate, Japan
Kagoshima, Japan
Kamogawa, Japan
Kitakyushu, Japan
Kobe, Japan
Kumamoto, Japan
Kyoto, Japan
Minato, Japan
Morioka, Japan
Nagoya, Japan
Nishinomiya, Japan
Sagamihara N/A, Japan
Sapporo, Japan
Shinjuku-Ku, Japan
Shizuoka, Japan
Suginami-Ku, Japan
Tokyo, Japan
Toyama, Japan
Toyonaka, Japan
Ube, Japan
Yokohama, Japan
Yonago N/A, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01799590     History of Changes
Other Study ID Numbers: CR013684
JNS019-JPN-03
First Posted: February 27, 2013    Key Record Dates
Results First Posted: May 6, 2013
Last Update Posted: May 31, 2013
Last Verified: May 2013
Keywords provided by Janssen Pharmaceutical K.K.:
Migraine
Topiramate
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs