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New Zelrix Sumatriptan Patch for Migraine

(Page 2)

Trial Objectives: To evaluate the effectiveness and tolerability of Zelrix.

Trial Methods:

• randomized, double-blind, placebo controlled

• 530 patients treated at 37 sites in the US

• Participant age range: 18–65 years

• participants with IHS defined Migraine treated one moderate to severe migraine attack with Zelrix or a placebo patch

• assessments included:

  • degree of freedom from pain

  • degree of relief from photophobia, phonophobia, nausea

  • sustained headache pain relief

  • need to use rescue medication.

  • Tolerability was evaluated by reports of adverse event reports, examining the skin when removing the patch, and the final study visit.

Trial Results:

Zelrix met the primary efficacy endpoint of a statistically significant improvement compared to placebo for pain freedom at two hours after patch application (18 percent vs. 9 percent, p=0.0092). Additional pre-defined two hour efficacy endpoints included:

  • Pain relief: 53 percent of patients treated with Zelrix compared with 29 percent for placebo (p<0.0001);

  • Nausea free: 84 percent of patients treated with Zelrix compared with 63 percent for placebo (p<0.0001);

  • Photophobia free: 51 percent of patients treated with Zelrix compared with 36 percent for placebo (p=0.0028);

  • Phonophobia free: 55 percent of patients treated with Zelrix compared with 39 percent for placebo (p=0.0002).

In addition to meeting the primary and key secondary endpoints, Zelrix demonstrated rapid efficacy and sustained pain relief with lower use of rescue medication:

  • Pain relief within one hour: 29 percent of patients treated with Zelrix compared with 19 percent for placebo (p=0.0135);

  • Nausea free within one hour: 71 percent of patients treated with Zelrix compared with 58 percent for placebo (p=0.0251);

  • Sustained pain relief (from two to 24 hours): 34 percent of patients treated with Zelrix compared with 21 percent for placebo (p=0.0015);

  • Use of rescue medication: 40 percent of patients treated with Zelrix compared with 60 percent for placebo (p<0.0001).

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