MigrainePhase 3NCT00237302
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
A Phase 3 study testing topiramate in people with Migraine, run by Ortho-McNeil Neurologics, Inc..
Trial summary
The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Migraine
- What is being tested?
- topiramate
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Sep 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who have had several attacks of headaches that meet the International Headache Society Classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity)
- Average of 3 to 10 migraine days per month for previous 3 months
- Weighs more than 20 kilograms (44 pounds)
- Able to swallow a tablet whole (without crushing it)
Who cannot join
- Took topiramate previously to prevent migraines but it was not effective
- Had to stop taking topiramate because of side effects
- Presence of cluster headaches, migraine aura without headache
- Had taken any medications for migraine prevention within 2 weeks before study start
- Presence of active liver disease or abnormal kidney function
About this study
Official title: A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects
The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.
Read the detailed description
Pediatric migraine headache is a common cause of severe recurring headaches in children, especially children between the ages of 5 and 15 years. These headaches can be disabling and tend to interfere with a child's daily activities, such as going to school or playing with friends. Because pediatric migraine children tend to be misdiagnosed, they are often not treated effectively. Topiramate, an anti-seizure medication, has been shown to prevent migraines in adults, and it has been approved to treat seizures in children as young as 2 years of age as add-on treatment (used with another drug) and also can be used alone (monotherapy) in children as young as 10 years old. Since topiramate has already been studied in children, information about its safety in children is available. In this study, children with migraine headaches will be identified. It is not necessary for the child to have the migraine aura (having blurry vision; seeing flashing lights) to be included in this study. This is a randomized, double-blind, placebo-controlled study of Topiramate (or placebo) given for 4 to 5 months. An optional 3-month open-label extension (topiramate only; no placebo) will follow. The objective of the study is to demonstrate that topiramate is effective and safe when used to prevent migraine headaches (with or without aura) in children. Safety will be assessed throughout the study.
Topiramate sprinkle capsules (or placebo), starting at 15 milligrams per day for 1st week; increased to 30 milligrams per day for week 2; increased to 50 milligrams (in tablets) per day in week 3, then adjusted as needed to 2 to 3 milligrams/kilogram/day for the rest of study (140 days total).
- Conditions
- Migraine
- Being tested
- topiramate
- Keywords
- pediatric migraine, migraine headache, migraine prophylaxis, migraine prevention, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine days per month (28 days) during the double-blind treatment period relative to the prospective baseline period.
Secondary outcomes (1)
Monthly rates of migraine episodes, non-migraine headache episodes, and total headache days; percentage of treatment responders; severity and duration of migraines; frequency and severity of associated migraine symptoms, and use of rescue medicines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJul 2001
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho McNeil Neurologics, Inc. Clinical Trial, Study director, Ortho-McNeil Neurologics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237302
- Sponsor's protocol ID
- CR002662
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00237302
- Acronym / sponsor ID
- CR002662
- Conditions
- Migraine
- Keywords
- pediatric migraine, migraine headache, migraine prophylaxis, migraine prevention, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2001
- Study completion
- Sep 2003 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
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 assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.
Detailed description
Pediatric migraine headache is a common cause of severe recurring headaches in children, especially children between the ages of 5 and 15 years. These headaches can be disabling and tend to interfere with a child's daily activities, such as going to school or playing with friends. Because pediatric migraine children tend to be misdiagnosed, they are often not treated effectively. Topiramate, an anti-seizure medication, has been shown to prevent migraines in adults, and it has been approved to treat seizures in children as young as 2 years of age as add-on treatment (used with another drug) and also can be used alone (monotherapy) in children as young as 10 years old. Since topiramate has already been studied in children, information about its safety in children is available. In this study, children with migraine headaches will be identified. It is not necessary for the child to have the migraine aura (having blurry vision; seeing flashing lights) to be included in this study. This is a randomized, double-blind, placebo-controlled study of Topiramate (or placebo) given for 4 to 5 months. An optional 3-month open-label extension (topiramate only; no placebo) will follow. The objective of the study is to demonstrate that topiramate is effective and safe when used to prevent migraine headaches (with or without aura) in children. Safety will be assessed throughout the study.
Topiramate sprinkle capsules (or placebo), starting at 15 milligrams per day for 1st week; increased to 30 milligrams per day for week 2; increased to 50 milligrams (in tablets) per day in week 3, then adjusted as needed to 2 to 3 milligrams/kilogram/day for the rest of study (140 days total).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who have had several attacks of headaches that meet the International Headache Society Classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity)
- Average of 3 to 10 migraine days per month for previous 3 months
- Weighs more than 20 kilograms (44 pounds)
- Able to swallow a tablet whole (without crushing it)
Key exclusion criteria (5 listed)
- Took topiramate previously to prevent migraines but it was not effective
- Had to stop taking topiramate because of side effects
- Presence of cluster headaches, migraine aura without headache
- Had taken any medications for migraine prevention within 2 weeks before study start
- Presence of active liver disease or abnormal kidney function
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 |
|---|---|---|
| topiramate | Drug | – |
Primary outcome
Number of migraine days per month (28 days) during the double-blind treatment period relative to the prospective baseline period.
1 secondary outcome
Monthly rates of migraine episodes, non-migraine headache episodes, and total headache days; percentage of treatment responders; severity and duration of migraines; frequency and severity of associated migraine symptoms, and use of rescue medicines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric SubjectsLink provided by the sponsor.
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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.
Ortho McNeil Neurologics, Inc. Clinical Trial study director
Ortho-McNeil Neurologics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Migraine, run by Ortho-McNeil Neurologics, Inc..
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 4 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of migraine days per month (28 days) during the double-blind treatment period relative to the prospective baseline period.. 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 19 May 2011.