Treximet Early Intervention Adolescent Migraine

NCT01016678 | Completed Phase 2 Results DMC

• 1 other identifier: TEAM2009
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• Number of Participants With 2-hour Pain Free Active Study Drug

  All data was collected and measured from self-reported patient diaries

  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

  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

  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.

  3 years

Study Arms (5)

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.

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.

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.

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.

Drug: Treximet; Drug: Placebo

Active, Active, Active, Active

OTHER

One fifth of the subject will treat all their migraines with Active Treximet.

Drug: Treximet

Interventions

Treximet DRUG

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.

Also known as: Imitrex and Naproxen Sodium

Active, Active, Active, Active; Active, Active, Active, Placebo; Active, Active, Placebo, Active; Active, Placebo, Active, Active; Placebo, Active, Active, Active

Placebo DRUG

Dummy pill comparator

Also known as: Sugar Pill

Active, Active, Active, Placebo; Active, Active, Placebo, Active; Active, Placebo, Active, Active; Placebo, Active, Active, Active

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Premiere Research Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (4)

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Andrew Hershey

Cincinnati, Ohio, 45229, United States

Location

Steve L. Linder

Dallas, Texas, 75230, United States

Location

Don W. Lewis

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

sumatriptan-naproxen; Sumatriptan; Naproxen; Sugars

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Paul Winner, DO
• Organization: Premiere Research Institute

pwinner777@aol.com

561-845-0500

Study Officials

• Paul K Winner, DO

  Premiere Research Institute

  PRINCIPAL INVESTIGATOR

• Andrew Hershey, MD

  Cincinnati Childrens Hospital

  PRINCIPAL INVESTIGATOR

• Steve L Linder, MD

  Dallas Pediatric Neurology Associates

  PRINCIPAL INVESTIGATOR

• Donald W Lewis, MD

  Childrens Hospital of the King's Daughters

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 4, 2016
• Results First Posted: May 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)