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Non-Steroidal Anti-Inflammatory Drug

Treximet for Migraine

Phase 4

Waitlist Available

Led By Barbara L Peterlin, DO

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Age greater than 18 years of age, migraine

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Summary

The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.

Eligible Conditions

Migraine

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Total Serum Adiponectin (T-ADP)

Secondary study objectives

High Molecular Weight (HMW)-Adiponectin (ADP)

High Molecular Weight (HMW): T-ADP

Leptin

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TreximetActive Control1 Intervention

Fourteen participants randomized to receive Treximet (sumatriptan \& naproxen) during an acute migraine attack. Blood drawn for immune \& inflammatory markers (adipocytokines,cytokines, sex hormones) at different time points - on presentation with moderate to severe migraine pain; then 30 minutes, 1 hour and 2 hours after administration of study drug (Treximet). Participants will be offered a traditional headache rescue medicine at 2 hours after administration of Treximet if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician.

Group II: Sugar PillPlacebo Group1 Intervention

Fourteen participants randomized to receive placebo during an acute migraine attack. Blood is drawn for immune \& inflammatory markers (adipocytokines,cytokines), sex hormones at different time points - on presentation with moderate to severe migraine pain, then 30 minutes, 1 hour and 2 hours after administration of placebo. Participants will be offered a traditional headache rescue medicine at 2 hours after administration of placebo if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician.

0 / 1Eligibility criteria met