Affiliations: Palm Beach Headache Center, Premiere Research
Institute, West Palm Beach, FL, USA
Note: [] Correspondence: Dr. Paul Winner, DO, Premiere Research
Institute, 4631 North Congress Avenue, Suite 200, 33407, West Palm Beach, FL,
USA. Tel.: +1 561 845 0500; Fax: +1 561 845 1974; E-mail:
Pwinner777@aol.com
Abstract: To assess the feasibility, efficacy, and tolerability of early
intervention with sumatriptan tablets formulated with RT Technology™
(sumatriptan RT) for adolescent migraine. Conventional triptan tablets, a
treatment of choice for migraine in adults, have not been demonstrated reliably
effective in adolescents in prospective, placebo-controlled studies. Neither
the early-intervention approach nor sumatriptan RT, a
fast-disintegrating/rapid-release oral tablet, has previously been studied in
adolescent migraineurs. Males or females 12 to 17-year-old diagnosed with
migraine with or without aura were asked to treat four migraine attacks over a
6 mo period with sumatriptan RT 100 mg as early intervention (i.e.,
administered within 30 min of attack onset while pain was still mild). Of the
35 patients who enrolled, 32 treated at least one migraine attack, and 23
treated all four-migraine attacks. Pain-free response 2 hr postdose (primary
endpoint) was reported in 71% of the 112 attacks treated. Migraine-free
response (i.e., no pain; no nausea, vomiting, photophobia, or phonophobia; and
no use of rescue medication) 2 hr postdose was reported in 69% of attacks.
Response rates were consistent from attack to attack. Rescue medication was
used in 19% of migraine attacks. In 112 attacks, a total of 25 adverse events
(none serious) were reported in nine patients. The most common adverse events
were worsening of symptoms (n=5), neck pain (n=4), and chest tightening (n=4).
Early intervention with sumatriptan RT constitutes a promising approach to
treating migraine in adolescents and warrants further assessment in controlled
clinical trials.
