Migraine Study in Adolescent Patients

Summary

This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Timeline

Start

2008-12

Primary completion

2010-05

Completion

2010-06

Outcome

Met primary endpoint

paper The attack 2 adjusted (age; baseline pain severity) 2-hour pain-free rates were higher with suma/nap 10/60 mg (29%; adjusted P = .003) PMID 22585767 ↗

paper 30/180 mg (27%; adjusted P = .003), and 85/500 mg (24%; adjusted P = .003) versus placebo (10%). PMID 22585767 ↗

Publications

• Background Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
• Derosier FJ, Lewis D, Hershey AD, Winner PK, Pearlman E, Rothner AD, Linder SL, Goodman DK, Jimenez TB, Granberry WK, Runken MC. Randomized trial of sumatriptan and naproxen sodium combination in adolescent migraine. Pediatrics. 2012 Jun;129(6):e1411-20. doi: 10.1542/peds.2011-2455. Epub 2012 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naproxen	Small molecule	60 mg	—
Subject	Naproxen	Small molecule	180 mg	—
Subject	Naproxen	Small molecule	500 mg	—
Subject	Sumatriptan	Unknown	10 mg	—
Subject	Sumatriptan	Unknown	30 mg	—
Subject	Sumatriptan	Unknown	85 mg	—

Indications