13 completed, 2 unknown, 1 terminated. 8 Phase 4, 2 Not applicable, 2 Phase 3, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 8 | Completed 7, Terminated 1 |
| Not applicable | 2 | Unknown 2 |
| Phase 3 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
Follow sumatriptan-naproxen: new trials by email Literature Review of sumatriptan-naproxen trials Research Report on sumatriptan-naproxen
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet Treximet, Placebo - Menstrual Migraine | Phase 4 | Completed | Cady, Roger, M.D. | 41 | 2011-05-01 | 2014-04-09 |
| Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine Sumatriptan/Naproxen Sodium, Naproxen Sodium - Migraine | Phase 4 | Completed | Cady, Roger, M.D. | 40 | 2010-12-01 | 2013-05-21 |
| Efficacy of Sumatriptan With Naprosyn in Migraine With Aura sumatriptan with naprosyn, placebo - Migraine With Aura | Not applicable | Unknown | Dent Neurologic Institute | 30 | 2010-10-01 | 2015-02-19 |
| Treximet in the Treatment of Chronic Migraine Sumatriptan/Naproxen Sodium, Naproxen Sodium - Chronic Migraine | Phase 4 | Completed | Cady, Roger, M.D. | 56 | 2010-09-01 | 2013-07-03 |
| Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction sumatriptan/naproxen sodium, Placebo - Post-Traumatic Headache | Phase 4 | Terminated | Cady, Roger, M.D. | 23 | 2010-05-01 | 2020-07-29 |
| Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap), Triptan monotherapy - Migraine Disorders | Completed | GlaxoSmithKline | 1 | 2010-03-01 | 2012-08-27 | |
| Treximet Early Intervention Adolescent Migraine Treximet, Placebo - Migraine | Phase 2 / Phase 3 | Completed | Premiere Research Institute | 104 | 2010-03-01 | 2016-05-04 |
| Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache sumatriptan and Treximet - Migraine | Completed | Gary E. Ruoff, M.D. | 30 | 2009-12-01 | 2013-08-05 | |
| Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex Treximet, Imitrex and two Aleve - Migraine | Phase 4 | Completed | Stephen H. Landy, M.D. | 50 | 2009-12-01 | 2011-10-13 |
| Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? Triptan, Treximet 85Mg-500Mg Tablet - Workplace Migraine Treatment | Phase 4 | Completed | The Cleveland Clinic | 60 | 2009-09-01 | 2018-05-01 |
| Ictal and Interictal Inflammatory Markers in Migraine Treximet, Placebo - Migraine | Phase 4 | Completed | Johns Hopkins University | 36 | 2009-09-01 | 2016-10-06 |
| Treximet ™ Pharmacy Budget Impact Model Database Validation Study Sumatriptan/Naproxen combination, other oral triptans - Migraine Disorders | Completed | GlaxoSmithKline | 61737 | 2009-07-01 | 2017-05-30 | |
| "Completeness of Response" Following Treatment With Treximet™ for Migraine sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet) - Migraine | Phase 4 | Completed | Cady, Roger, M.D. | 147 | 2009-06-01 | 2011-01-25 |
| Treximet in Acute Migraine Headache: Assessing Cognitive Function Treximet, Migraine rescue medication of choice - Migraine Headache, Cognitive Impairment | Not applicable | Unknown | Neurological Research Center | 30 | 2009-02-01 | 2009-02-05 |
| A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses. This is a pharmacokinetic study (Treximet) - Migraine Disorders | Phase 1 | Completed | GlaxoSmithKline | 50 | 2008-11-04 | 2017-06-19 |
| TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults TREXIMET®, Butalbital-containing Combination Medications (BCM), placebo - Migraine Disorders, Migraine, Acute | Phase 3 | Completed | GlaxoSmithKline | 375 | 2008-02-01 | 2010-12-29 |
Migraine Disorders (14) · Headache (3) · Cognitive Dysfunction (2) · Brain Injuries (1) · Migraine with Aura (1) · Post-Traumatic Headache (1)
Cady, Roger, M.D. (5) · GlaxoSmithKline (4) · Dent Neurologic Institute (1) · Gary E. Ruoff, M.D. (1) · Johns Hopkins University (1) · Neurological Research Center (1) · Premiere Research Institute (1) · Stephen H. Landy, M.D. (1) · The Cleveland Clinic (1)
United States (14)
Roger K Cady, MD (5) · Andrew Hershey, MD (1) · Barbara L Peterlin, DO (1) · Donald W Lewis, MD (1) · Gary E Ruoff, MD (1) · Jennifer S Kriegler, MD (1) · Keith R Edwards, M.D. (1) · Laszlo L Mechtler, MD (1) · Paul K Winner, DO (1) · Stephen H Landy, M.D. (1) · Steve L Linder, MD (1)
PMID 16492233, PMID 17501849, PMID 17955107, PMID 18384420, PMID 19486178, PMID 21592098, PMID 22103635, PMID 23406052, PMID 24020994