title: Treatment of chronic migraine: a 3-month comparator study of naproxen sodium vs SumaRT/Nap.
abstract: OBJECTIVE
  To compare the use of a combination of 85 mg sumatriptan plus 500 mg naproxen sodium in a combination tablet with 500 mg naproxen sodium in an identically appearing tablet when used as a daily preventative and acute treatment for 1 month and episodic acute treatment for an additional 2 months in patients with chronic migraine.
  
  
  BACKGROUND
  To date, there has been minimal study of acute medications for patients with chronic migraine. Consequently, there is a paucity of study methodology or evidence-based guidance on the use of acute treatment medications in patients with chronic migraine.
  
  
  METHODS
  This two-center, double-blind, randomized, parallel-group, comparator pilot trial of 28 subjects, 18 to 65 years of age, with ICHD-II defined chronic migraine, was designed to generate hypotheses about the efficacy of 2 established acute migraine medications used both as a daily preventive treatment (month 1) and episodic acute treatment (months 1, 2, and 3). Subjects were randomized 1:1 to treat daily with SumaRT/Nap (85 mg sumatriptan + 500 mg naproxen sodium) (group A) or naproxen sodium (500 mg) (group B) in a prophylactic strategy for 1 month followed by 2 months of the same medications used for episodic acute treatment.
  
  
  RESULTS
  The combination of SumaRT/Nap used over a 3-month period did not appear to significantly reduce the number of migraine headache days. In the subset of subjects using naproxen sodium and completing the study per protocol, there was a marked reduction in migraine headache days (P < .02 vs 0.25, respectively). Duration of migraine from treatment to pain free decreased in both groups, but was more robust in group B from baseline to month 3. Subjects in group B completing the study per protocol reported a 56% reduction in headache days vs 8% for group A. Subjects in group A and group B completing the study per protocol had considerably better 2-hour headache relief than subjects withdrawing early from the study. More subjects in group B prematurely withdrew from the study because of lack of efficacy (5 vs 1, respectively). Despite using significant quantities of acute medication during month 1, there was a reduction of acute medication in month 2 and 3 vs baseline vs month 1, particularly in the naproxen group.
  
  
  CONCLUSIONS
  A combination of SumaRT/Nap (group A) did not appear to reduce migraine headache frequency over a 3-month period. Subjects using naproxen sodium (group B) alone and completing the study per protocol had a marked statistically significant reduction in migraine headache days. Both groups completing the study per protocol had experienced clinically meaningful 2-hour headache relief. This suggests there may be a subset of patients with chronic migraine that are responsive to high doses of naproxen as an acute intervention with a significant prophylactic benefit. Subjects randomized to SumaRT/Nap experience benefit, primarily as an acute intervention. This hypothesis may warrant future larger scale clinical trials. Frequent dosing of SumaRT/Nap or naproxen sodium was well tolerated in this study.
authors.affiliation: Headache Care Center, Springfield, MO, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Cady
authors.forename: Robert
authors.initials: R
authors.lastname: Nett
authors.forename: Kent
authors.initials: K
authors.lastname: Dexter
authors.forename: Fred
authors.initials: F
authors.lastname: Freitag
authors.forename: M E
authors.initials: ME
authors.lastname: Beach
authors.forename: Heather R
authors.initials: HR
authors.lastname: Manley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002908:Chronic Disease; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D008875:Middle Aged; D008881:Migraine Disorders / Q000175:diagnosis* / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage*; D010865:Pilot Projects; D058825:Serotonin 5-HT1 Receptor Agonists / Q000008:administration & dosage*; D018170:Sumatriptan / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D058825:Serotonin 5-HT1 Receptor Agonists; D009288:Naproxen; D018170:Sumatriptan
keywords: acute treatment; chronic migraine; episodic migraine; preventive treatment