The headache- and migraine-inducing effects of apremilast in women with migraine without aura

Conditions

Migraine without aura

Brief summary

Difference in the occurrence of migraine-like attacks between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration)

Detailed description

Difference in headache intensities over time between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration), The occurrence of any headache, irrespective of migraine criteria, between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration), Difference in heart rate and mean arterial pressure (MAP) until 90 minutes post-administration between apremilast- and placebo-treated women with migraine without aura, Difference in the incidence of adverse events during the entire observational period (until 12 hours post-administration) between apremilast- and placebo-treated women with migraine without aura

Related papers

No related papers found yet.

Interventions

DRUGApremilast STADA 30 mg

DRUGfilmomhulde tabletten

DRUGLactose monohydrate

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Difference in the occurrence of migraine-like attacks between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration)	—

Secondary

Measure	Time frame
Difference in headache intensities over time between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration), The occurrence of any headache, irrespective of migraine criteria, between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration), Difference in heart rate and mean arterial pressure (MAP) until 90 minutes post-administration between apremilast- and placebo-treated women with migraine without aura, Difference in the incidence of adverse events during the entire observational period (until 12 hours post-administration) between apremilast- and placebo-treated women with migraine without aura	—

Measure

Time frame

Difference in headache intensities over time between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration), The occurrence of any headache, irrespective of migraine criteria, between apremilast- and placebo-treated women with migraine without aura during the entire observational period (until 12 hours post-administration), Difference in heart rate and mean arterial pressure (MAP) until 90 minutes post-administration between apremilast- and placebo-treated women with migraine without aura, Difference in the incidence of adverse events during the entire observational period (until 12 hours post-administration) between apremilast- and placebo-treated women with migraine without aura

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Outcome results

None listed