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The primary objective of the TEENZ Study (NCT01211145) was to assess the efficacy of Zolmitriptan nasal spray in the acute treatment of adolescent migraine patients (ages 12 to 17 years), as measured by the primary outcome variable of pain-free status at 2 hours’ post-treatment.
Zolmitriptan is a
selective serotonin receptor agonist used for the treatment of migraines and
headaches. In this study, the superiority, efficacy and safety of its nasal
spray has been detected.
The primary
objective of the TEENZ Study (NCT01211145) was to assess the efficacy of Zolmitriptan
nasal spray in the acute treatment of adolescent migraine patients (ages 12 to
17 years), as measured by the primary outcome variable of pain-free status at 2
hours’ post-treatment.
This randomized,
double-blind, placebo-controlled, four-arm parallel group study compared Zolmitriptan
nasal spray with placebo in the treatment of a single episode of adolescent
migraine. Patients completed a 30-day run-in period to treat a single migraine
attack with single-blind placebo nasal spray. Eligible patients, who had not
responded to placebo, were randomized to one of three Zolmitriptan nasal spray
doses (5, 2.5, or 0.5 mg) or placebo in a ratio of 5:3:3:5 according to a
computer-generated randomization scheme. Patients completed diaries for 24
hours after treatment, recording headache pain scores, adverse events (AEs),
and medications taken.
In an interim
futility analysis, Zolmitriptan nasal spray doses of 0.5 and 2.5 mg were
declared futile relative to placebo and further randomization to these treatment
arms was discontinued. Of 1653 patients enrolled into the study, 855 patients
failed to meet study eligibility criteria and were considered screen failures.
The most common reason for screen failure was response to placebo challenge
(325 patients [38.0%]). Of the 798 patients who were randomized to treatment,
721 (90.4%) completed the study period. Of these, 657 (82.3%) treated a
migraine within the study period and contributed data for analysis.
Zolmitriptan nasal spray 5 mg was significantly more effective than placebo in
achieving pain-free status at 2 hours after treatment (P < .001), with 30%
of patients achieving pain-free status at 2 hours’ vs 17% of placebo-treated
patients (OR 2.18; 95% CI 1.40, 3.39). Zolmitriptan nasal spray 5 mg was also
more effective than placebo in achieving pain-free status at 3 and 4 hours’
post-treatment (45 vs 24%, and 56 vs 39%; both P < .001). Zolmitriptan nasal
spray 5 mg was also more effective than placebo in achieving headache response
at 2, 3, and 4 hours after treatment (51 vs 39%, 61 vs 48%, and 69 vs 57%,
respectively; all P ≤ .011). Zolmitriptan nasal spray was well-tolerated at all
doses. Dysgeusia was the most frequently reported AE, with greater frequencies
reported in active treatment groups versus placebo. No serious AEs or AEs
leading to discontinuation were reported. Most AEs were mild or moderate in
severity, and consistent with the known profile of Zolmitriptan in adult and
adolescent populations.
Zolmitriptan
nasal spray was well-tolerated in the acute treatment of adolescent (ages 12 to
17 years) migraine. Zolmitriptan 5 mg nasal spray demonstrated superior
efficacy compared with placebo for the primary efficacy endpoint of pain-free
status 2 hours after treatment and the efficacy of the 5 mg dose was supported
by the majority of secondary efficacy endpoints.
Headache
Efficacy and tolerability of zolmitriptan nasal spray for the treatment of acute migraine in adolescents: Results of a randomized, double-blind, multi-center, parallel-group study (TEENZ)
Paul Winner et al.
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