MigrainePhase 3NCT00210483
A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents
A Phase 3 study testing almotriptan malate in people with Migraine, run by Janssen-Ortho LLC.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- almotriptan malate
- How many people
- 866 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jul 2005
- 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
- Diagnosis of migraine with or without aura for > 1 year
- Average of 1 to 6 moderate or severe migraines per month for 2 months before entering the study
- Untreated migraines lasting at least 4 hours
- At least 24 hours between migraines
- Able to tell the difference between migraines and other types of headache
- If female, using birth control
Who cannot join
- Chronic tension or cluster headache
- Prolonged aura
- Specific types of migraine
- > 6 nonmigraine headaches per month
- High blood pressure for the age
- Medical history with specific significant conditions affecting the liver, kidney, heart or other body systems
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- Conditions that might affect the way the body absorbs or processes a drug
- Positive blood tests for Hepatitis B or C
- Recent head or neck injury
- Body weight outside given parameters
- Unable to take sumatriptan
- Abusing drugs or alcohol
- Pregnant or breast-feeding
- Use of antimigraine medication that might interfere with the study, of antimigraine medication for < 2 weeks, of lithium or monoamine oxidase inhibitors in past 2 weeks, of an investigational drug within 2 months
- Refuse to abstain from taking medicine with ergotamine or any other drug like almotriptan within 48 hours before and 24 hours after taking study medication, or drugs containing opiates or antivomiting medicine within 48 hours before and 2 hours after taking study medication
- Use of simple pain medicines within 24 hours (like aspirin)
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Oral Almotriptan Malate (AXERT®) 6.25 mg, 12.5 mg, and 25 mg in the Acute Treatment of Migraine in Adolescents
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. In this study, adolescents will be given a single dose of study medication to treat one migraine headache.
Read the detailed description
Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. Other studies have shown that almotriptan is effective and well tolerated in adults. Migraines in teenagers/adolescents are very similar to migraines in adults, except that the duration is usually less in adolescents (they last 1 to 24 hours in adolescents). This study will evaluate the usefulness of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. This is a randomized, double-blind, parallel-group, and placebo-controlled study. During a 30-day run-in period, patients will treat their migraines as they normally would. During this time, the frequency and severity of headaches will be recorded. At the second visit, patients will be randomized (like with the toss of a coin) to a treatment group to receive one oral dose of almotriptan malate (AXERT®) 6.25, 12.5, or 25 milligrams or placebo. Approximately the same number of patients will be assigned to each of the four treatment groups. Patients will take this one-time dose when the next migraine of at least moderate severity occurs. Patients will record assessments in a diary for up to 24 hours after the study drug is given to help determine the drug's effect on headache pain intensity. Patients will return for a third visit within 2 to 14 days from taking the study medication. A physical examination, electrocardiogram (a painless test of the heart), and laboratory tests will be performed at the first and third visits. The objective of this study is to determine the effectiveness and tolerability of 3 dosage strengths of almotriptan malate (AXERT®) in adolescents with migraine headaches.
Almotriptan oral tablets, 6.25, 12.5, or 25 milligrams, or placebo
- Conditions
- Migraine
- Being tested
- almotriptan malate
- Keywords
- pain, Migraine, aura, headache
- Medical subject headings
- Migraine Disorders, Pain, Epilepsy, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
almotriptan malateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain
Secondary outcomes (1)
Efficacy, symptoms, headache pain free at time points 0.25, 0.5, 1, 1.5 hours postdose; incidence of headache recurrence in 2 to 24 hours and use of rescue medication 2 to 24 hours postdose; pain relief or pain free at 24 hours; all by patient assessment
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 startJul 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Janssen Ortho LLC Clinical Trial, Study director, Janssen-Ortho LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210483
- Sponsor's protocol ID
- CR004567
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 17 May 2011
- Results posted
- No
Publications
Linder SL, Mathew NT, Cady RK, Finlayson G, Ishkanian G, Lewis DW. Efficacy and tolerability of almotriptan in adolescents: a randomized, double-blind, placebo-controlled trial. Headache. 2008 Oct;48(9):1326-36. doi: 10.1111/j.1526-4610.2008.01138.x. Epub 2008 May 14.
PubMed 18484981
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Oral Almotriptan Malate (AXERT®) 6.25 mg, 12.5 mg, and 25 mg in the Acute Treatment of Migraine in Adolescents
- ClinicalTrials.gov ID
- NCT00210483
- Acronym / sponsor ID
- CR004567
- Conditions
- Migraine
- Keywords
- pain, Migraine, aura, headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Janssen-Ortho LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Jul 2003
- Study completion
- Jul 2005 (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 purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. In this study, adolescents will be given a single dose of study medication to treat one migraine headache.
Detailed description
Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. Other studies have shown that almotriptan is effective and well tolerated in adults. Migraines in teenagers/adolescents are very similar to migraines in adults, except that the duration is usually less in adolescents (they last 1 to 24 hours in adolescents). This study will evaluate the usefulness of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. This is a randomized, double-blind, parallel-group, and placebo-controlled study. During a 30-day run-in period, patients will treat their migraines as they normally would. During this time, the frequency and severity of headaches will be recorded. At the second visit, patients will be randomized (like with the toss of a coin) to a treatment group to receive one oral dose of almotriptan malate (AXERT®) 6.25, 12.5, or 25 milligrams or placebo. Approximately the same number of patients will be assigned to each of the four treatment groups. Patients will take this one-time dose when the next migraine of at least moderate severity occurs. Patients will record assessments in a diary for up to 24 hours after the study drug is given to help determine the drug's effect on headache pain intensity. Patients will return for a third visit within 2 to 14 days from taking the study medication. A physical examination, electrocardiogram (a painless test of the heart), and laboratory tests will be performed at the first and third visits. The objective of this study is to determine the effectiveness and tolerability of 3 dosage strengths of almotriptan malate (AXERT®) in adolescents with migraine headaches.
Almotriptan oral tablets, 6.25, 12.5, or 25 milligrams, or placebo
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 (6 listed)
- Diagnosis of migraine with or without aura for > 1 year
- Average of 1 to 6 moderate or severe migraines per month for 2 months before entering the study
- Untreated migraines lasting at least 4 hours
- At least 24 hours between migraines
- Able to tell the difference between migraines and other types of headache
Key exclusion criteria (16 listed)
- Chronic tension or cluster headache
- Prolonged aura
- Specific types of migraine
- > 6 nonmigraine headaches per month
- High blood pressure for the 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 |
|---|---|---|
| almotriptan malate | Drug | – |
Primary outcome
Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain
1 secondary outcome
Efficacy, symptoms, headache pain free at time points 0.25, 0.5, 1, 1.5 hours postdose; incidence of headache recurrence in 2 to 24 hours and use of rescue medication 2 to 24 hours postdose; pain relief or pain free at 24 hours; all by patient assessment
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 17 May 2011.
- Derived from this study: PubMed 18484981Linder SL, Mathew NT, Cady RK, Finlayson G, Ishkanian G, Lewis DW. Efficacy and tolerability of almotriptan in adolescents: a randomized, double-blind, placebo-controlled trial. Headache. 2008 Oct;48(9):1326-36. doi: 10.1111/j.1526-4610.2008.01138.x. Epub 2008 May 14.
- Axert in Pediatric MigraineLink 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.
Janssen Ortho LLC Clinical Trial study director
Janssen-Ortho LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing almotriptan malate in people with Migraine, run by Janssen-Ortho LLC.
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 6 inclusion and 16 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 17 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?
Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210483, which also lists 1 linked publication.
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 17 May 2011.