MigrainePhase 2/3TEAMNCT01016678

Treximet Early Intervention Adolescent Migraine

A Phase 2/3 study testing Treximet in people with Migraine, run by Premiere Research Institute at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Migraine
What is being tested?: Treximet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 4 sitesUnited States
Study dates: Mar 2010to Jul 2014
Phase: Phase 2/3
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female subjects between the ages of 12-17.
Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least 1 but no more than 8 attacks per month on average over the past 6 months prior to screening visit. Attacks should be moderate to severe and last for at least 3 hours.
Subject is able to distinguish migraine from other headaches and can determine when a mild headache will become a moderate/severe migraine.
Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of approved contraception.
Subject and subject's parent or legal guardian are able to read and write English.
Subject is able to read, comprehend, and complete subject diaries.
Subjects' parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.
Subject is willing and able to provide Informed Assent prior to entry into the study.

Who cannot join

Subjects meeting any of the following criteria must not be enrolled in the study:
Subject is < 74 pounds (33.3kg) and no greater than 260lbs (117.9kg)
Subject has greater than or equal to 15 headache days per month in total.
Subject has secondary headaches i.e. complex migraine, hemiplegic, or basilar.
Subject, in investigators opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
Subject has uncontrolled hypertension at screening or is taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

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Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in the study.
Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with the above.
Subject has a evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an anti-epileptic drug for seizure control within 5 years prior to screening.
Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
Subject has a hypersensitivity, allergy, intolerance, or contraindication to the use any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps or asthma.
Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized for at least two months for either chronic or intermittent migraine prophylaxis or other co-morbid condition.
Subject has taken or plans to take a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. Johns Wort (Hypericum perforatum), anytime within the two weeks prior to screening and two weeks past exit of study.
Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.
Subject is pregnant, actively trying to become pregnant, or breast feeding or Subject is not willing to have pregnancy test(s).
Subject has evidence of illicit drug or alcohol abuse within the last year or any concurrent psychiatric condition which, in the investigator's opinion, will likely interfere with study conduct and participation in the trial.
Subject has participated in any investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Andrew Hershey
Cincinnati, Ohio, 45229
Steve L. Linder
Dallas, Texas, 75230
Don W. Lewis
Norfolk, Virginia, 23507
Premiere Research Institute
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate Efficacy & Safety of ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents

The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.

Read the detailed description

There are two primary treatment comparisons for this study: 1) the percentage of subjects' pain free at 2 hours after treatment with TREXIMET versus placebo across attacks, and 2) the percentage of subjects who are sustained pain free at 24 hours after treatment with TREXIMET versus placebo across attacks.

The following alternative hypothesis will be tested to see if there is a difference in the proportion of subjects who are pain free at 2 hours with TREXIMET versus placebo at all attacks, OR there is a difference in the proportion of subjects who are sustained pain free at 24 hours with TREXIMET versus placebo at all attacks.

Conditions: Migraine
Being tested: Treximet, Placebo
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TreximetDrug
Also called Imitrex and Naproxen Sodium
85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
PlaceboDrug
Also called Sugar Pill
Dummy pill comparator

Study groups in NCT01016678
Study group	Role	What they receive
Active, Active, Active, Placebo	Other	One fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo. Receives: Drug: Treximet; Drug: Placebo
Active, Active, Placebo, Active	Other	This is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet. Receives: Drug: Treximet; Drug: Placebo
Active, Placebo, Active, Active	Other	Approximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug. Receives: Drug: Treximet; Drug: Placebo
Placebo, Active, Active, Active	Other	One fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet. Receives: Drug: Treximet; Drug: Placebo
Active, Active, Active, Active	Other	One fifth of the subject will treat all their migraines with Active Treximet. Receives: Drug: Treximet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With 2-hour Pain Free Active Study Drug
All data was collected and measured from self-reported patient diaries
Measured: 3 years
Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
All data was collected and measured from self-reported patient diaries
Measured: 3 years
Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
All data was collected and measured from self-reported patient diaries
Measured: 3 years

Secondary outcomes (1)

To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.
Collected from patient reported paper diaries
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jul 2014

First posted19 Nov 2009 (estimated)
Study startMar 2010
Primary completionJun 2014
Study completionJul 2014

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01016678
Sponsor's protocol ID: TEAM2009
Acronym: TEAM
Status last verified: Mar 2016
First submitted: 18 Nov 2009
Last updated: 4 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: There is no plan in place to enter every single patient in separtely

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate Efficacy & Safety of ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents
ClinicalTrials.gov ID: NCT01016678
Acronym / sponsor ID: TEAM / TEAM2009
Conditions: Migraine
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Premiere Research InstituteUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Mar 2010
Primary completion: Jun 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 19 Nov 2009 (estimated)
Results: Posted 4 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Active, Active, Active, Placebo	Other	Drug: Treximet, Drug: PlaceboOne fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo.
Active, Active, Placebo, Active	Other	Drug: Treximet, Drug: PlaceboThis is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet.
Active, Placebo, Active, Active	Other	Drug: Treximet, Drug: PlaceboApproximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug.
Placebo, Active, Active, Active	Other	Drug: Treximet, Drug: PlaceboOne fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet.
Active, Active, Active, Active	Other	Drug: TreximetOne fifth of the subject will treat all their migraines with Active Treximet.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male or female subjects between the ages of 12-17.
Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least 1 but no more than 8 attacks per month on average over the past 6 months prior to screening visit. Attacks should be moderate to severe and last for at least 3 hours.
Subject is able to distinguish migraine from other headaches and can determine when a mild headache will become a moderate/severe migraine.
Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of approved contraception.
Subject and subject's parent or legal guardian are able to read and write English.

Key exclusion criteria (18 listed)

Subject is < 74 pounds (33.3kg) and no greater than 260lbs (117.9kg)
Subject has greater than or equal to 15 headache days per month in total.
Subject has secondary headaches i.e. complex migraine, hemiplegic, or basilar.
Subject, in investigators opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
Subject has uncontrolled hypertension at screening or is taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

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
TreximetAlso: Imitrex and Naproxen Sodium85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.	Drug	Active, Active, Active, Active, Active, Active, Active, Placebo, Active, Active, Placebo, Active, Active, Placebo, Active, Active, Placebo, Active, Active, Active
PlaceboAlso: Sugar PillDummy pill comparator	Drug	Active, Active, Active, Placebo, Active, Active, Placebo, Active, Active, Placebo, Active, Active, Placebo, Active, Active, Active

Primary outcome

Number of Participants With 2-hour Pain Free Active Study Drug
Time frame: 3 years
All data was collected and measured from self-reported patient diaries
Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
Time frame: 3 years
All data was collected and measured from self-reported patient diaries
Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
Time frame: 3 years
All data was collected and measured from self-reported patient diaries

1 secondary outcome

To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.
Time frame: 3 years

Results and safety

Results posted to the registry on 4 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active, Active, Active, Placebo	20	18
Active, Active, Placebo, Active	17	14
Active, Placebo, Active, Active	19	15
Placebo, Active, Active, Active	19	19
Active, Active, Active, Active	19	13

Primary outcome: Number of Participants With 2-hour Pain Free Active Study Drug

Time frame: 3 years. Number. Unit: Participants

Measure	Migraine Attack 1 n = 94	Migraine Attack 2 n = 90	Migraine Attack 3 n = 82	Migraine Attack 4 n = 81
Pain Free at 2 hours post dose for Active Treatmen	35	23	21	24
Pain Free at 2 Hours Post Dose for Placebo	2	2	3	6

Migraine Attack 1 vs Migraine Attack 2 vs Migraine Attack 3 vs Migraine Attack 4: Difference in percentages: 18, p = 0.0038, Chi-squared

Population analysed: The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis

Primary outcome: Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose

Time frame: 3 years. Number. Unit: percentage of attacks

Measure	Active Drug n = 54	Placebo n = 13
Value	86	78

Active Drug vs Placebo: difference in percentages: 8, p = 0.1294, Chi-squared

Population analysed: Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours

Primary outcome: Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention

Time frame: 3 years. Number. Unit: percentage of attacks

Measure	Active Drug n = 94	Placebo n = 74
Value	32	18

Population analysed: 94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Entire Study 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active, Active, Active, Placebo	1 of 20 (5%)	2 of 20 (10%)	Not reported
Active, Active, Placebo, Active	0 of 17 (0%)	8 of 17 (47.1%)	Not reported
Active, Placebo, Active, Active	0 of 19 (0%)	5 of 19 (26.3%)	Not reported
Placebo, Active, Active, Active	0 of 19 (0%)	8 of 19 (42.1%)	Not reported
Active, Active, Active, Active	0 of 19 (0%)	7 of 19 (36.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan in place to enter every single patient in separtely

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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.

Paul K Winner, DO principal investigator

Premiere Research Institute

Andrew Hershey, MD principal investigator

Cincinnati Childrens Hospital

Steve L Linder, MD principal investigator

Dallas Pediatric Neurology Associates

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Treximet in people with Migraine, run by Premiere Research Institute at 4 sites in United States.

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 8 inclusion and 18 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

Yes. Results are posted in the registry (first posted 4 May 2016). 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?

Number of Participants With 2-hour Pain Free Active Study Drug (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT01016678.

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 4 May 2016.