MigrainePhase 3NCT00210535
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
A Phase 3 study of Migraine and Vascular Headaches, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Migraine, Vascular Headaches
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Nov 2006
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History of migraine (with or without aura) conforming to International Headache Society (IHS) criteria for pediatric subjects for >=6 months prior to screening
- Requires migraine prophylactic therapy, and if previously treated to prevent attacks, had unsatisfactory response to therapy
- Experienced an average of 3 to 12 migraine attacks and no more than 14 headache days per month during the 3 months prior to the study
- Females must be sexually abstinent, surgically sterile, or using adequate contraceptive measures, and have negative pregnancy tests before and during the study
Who cannot join
- Currently taking or previously unable to tolerate topiramate, or previously failed therapy with topiramate for migraine prophylaxis
- Has mixed headaches and is unable to distinguish migraines from other headache types
- Overuses pain medications or specific agents for abortive treatment of migraine attacks
- Has a body mass index (BMI) greater than 40 or weighs more than 200 pounds, or is markedly underweight (below 5th percentile) for his or her age
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age).
Read the detailed description
This is an outpatient, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of 2 dosages of topiramate (50 and 100 milligrams/day) compared with placebo in the prevention of migraine attacks in children 12 to 17 years of age. The study is composed of 3 phases: pretreatment, double-blind treatment for 4 months (16 weeks), and posttreatment. During the study, patients will maintain headache and medication records to document the following: occurrence and duration of headaches; severity of headache pain; whether or not the headache is pulsating or aggravated by physical activity; associated symptoms, such as nausea, vomiting, photophobia, phonophobia, abdominal pain; and medication taken to relieve headache pain or symptoms. Assessment of efficacy include the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind treatment phase compared with prospective BL period. In addition, the percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase will be assessed. Safety assessments include the incidence of adverse events, measurement of vital signs (pulse, blood pressure, oral temperature), results of pregnancy tests, physical and neurologic examinations, clinical laboratory tests (hematology, biochemistry, and urinalysis), and monitoring for visual or ocular disturbances, heat intolerance, renal or urinary disturbance, depression and rash. The study hypothesis is that the percent reduction in frequency of monthly (28-day) migraine attacks (using the 48-hour rule) from the prospective baseline period (pretreatment phase) to the last 12 weeks of the double-blind phase will be significantly better for the topiramate groups than for the placebo group. Topiramate tablets (25 milligrams) or placebo, beginning at 25mg once daily (Week 1), increasing to twice daily total of 50mg or 100mg (Week 4). Maximum dosage of topiramate (or placebo) continues for next 12 weeks. Dosage may be reduced once at investigator's discretion.
- Conditions
- Migraine, Vascular Headaches
- Being tested
- Topiramate; Placebo
- Keywords
- Topiramate, Migraine, Migraine headache, Migraine prevention, Pediatric
- Medical subject headings
- Migraine Disorders, Vascular Headaches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate; PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in the frequency of monthly migraine attacks (using 48-hour rule) over the last 12 weeks of the double-blind treatment phase compared with the 4-week prospective baseline period.
Secondary outcomes (1)
Percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the prospective baseline period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2005
- Study completionNov 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210535
- Sponsor's protocol ID
- CR002245
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age
- ClinicalTrials.gov ID
- NCT00210535
- Acronym / sponsor ID
- CR002245
- Conditions
- Migraine, Vascular Headaches
- Keywords
- Topiramate, Migraine, Migraine headache, Migraine prevention, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 21 Sep 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 primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age).
Detailed description
This is an outpatient, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of 2 dosages of topiramate (50 and 100 milligrams/day) compared with placebo in the prevention of migraine attacks in children 12 to 17 years of age. The study is composed of 3 phases: pretreatment, double-blind treatment for 4 months (16 weeks), and posttreatment. During the study, patients will maintain headache and medication records to document the following: occurrence and duration of headaches; severity of headache pain; whether or not the headache is pulsating or aggravated by physical activity; associated symptoms, such as nausea, vomiting, photophobia, phonophobia, abdominal pain; and medication taken to relieve headache pain or symptoms. Assessment of efficacy include the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind treatment phase compared with prospective BL period. In addition, the percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase will be assessed. Safety assessments include the incidence of adverse events, measurement of vital signs (pulse, blood pressure, oral temperature), results of pregnancy tests, physical and neurologic examinations, clinical laboratory tests (hematology, biochemistry, and urinalysis), and monitoring for visual or ocular disturbances, heat intolerance, renal or urinary disturbance, depression and rash. The study hypothesis is that the percent reduction in frequency of monthly (28-day) migraine attacks (using the 48-hour rule) from the prospective baseline period (pretreatment phase) to the last 12 weeks of the double-blind phase will be significantly better for the topiramate groups than for the placebo group. Topiramate tablets (25 milligrams) or placebo, beginning at 25mg once daily (Week 1), increasing to twice daily total of 50mg or 100mg (Week 4). Maximum dosage of topiramate (or placebo) continues for next 12 weeks. Dosage may be reduced once at investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- History of migraine (with or without aura) conforming to International Headache Society (IHS) criteria for pediatric subjects for >=6 months prior to screening
- Requires migraine prophylactic therapy, and if previously treated to prevent attacks, had unsatisfactory response to therapy
- Experienced an average of 3 to 12 migraine attacks and no more than 14 headache days per month during the 3 months prior to the study
- Females must be sexually abstinent, surgically sterile, or using adequate contraceptive measures, and have negative pregnancy tests before and during the study
Key exclusion criteria (4 listed)
- Currently taking or previously unable to tolerate topiramate, or previously failed therapy with topiramate for migraine prophylaxis
- Has mixed headaches and is unable to distinguish migraines from other headache types
- Overuses pain medications or specific agents for abortive treatment of migraine attacks
- Has a body mass index (BMI) greater than 40 or weighs more than 200 pounds, or is markedly underweight (below 5th percentile) for his or her age
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; Placebo | Drug | – |
Primary outcome
Percent reduction in the frequency of monthly migraine attacks (using 48-hour rule) over the last 12 weeks of the double-blind treatment phase compared with the 4-week prospective baseline period.
1 secondary outcome
Percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the prospective baseline period.
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 8 Jun 2011.
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of AgeLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Migraine and Vascular Headaches, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 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 8 Jun 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?
Percent reduction in the frequency of monthly migraine attacks (using 48-hour rule) over the last 12 weeks of the double-blind treatment phase compared with the 4-week 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 8 Jun 2011.