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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 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.

Find a Location

Who is running the clinical trial?

University of Toledo Health Science CampusOTHER
40 Previous Clinical Trials
16,368 Total Patients Enrolled
1 Trials studying Migraine
68 Patients Enrolled for Migraine
Johns Hopkins UniversityLead Sponsor
2,317 Previous Clinical Trials
14,871,913 Total Patients Enrolled
3 Trials studying Migraine
202 Patients Enrolled for Migraine
The Cleveland ClinicOTHER
1,049 Previous Clinical Trials
1,370,699 Total Patients Enrolled
5 Trials studying Migraine
407 Patients Enrolled for Migraine
~2 spots leftby Oct 2025
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