TY - JOUR

T1 - Toward a pragmatic migraine model for drug testing

T2 - 1. Cilostazol in healthy volunteers

AU - Hansen, Emma Katrine

AU - Guo, Song

AU - Ashina, Messoud

AU - Olesen, Jes

N1 - © International Headache Society 2015.

PY - 2016/2

Y1 - 2016/2

N2 - BACKGROUND: A model for the testing of novel antimigraine drugs should ideally use healthy volunteers for ease of recruiting. Cilostazol provokes headache in healthy volunteers with some migraine features such as pulsating pain quality and aggravation by physical activity. Therefore, this headache might respond to sumatriptan, a requirement for validation. The hypothesis of the present study was that sumatriptan but not placebo is effective in cilostazol-induced headache in healthy individuals.METHODS: In a double-blind, randomized, cross-over design, 30 healthy volunteers of both sexes received cilostazol 200 mg on two separate days, each day followed by oral self-administered placebo or sumatriptan 50 mg. Headache response and accompanying symptoms were registered in a questionnaire by the participants themselves.RESULTS: Cilostazol induced a reproducible headache in 90% of the participants. The headache had several migraine-like features in most individuals. Median peak headache score was 2 on the sumatriptan day and 3 on the placebo day (p = 0.17). There was no reduction in headache intensity two hours after sumatriptan (p = 0.97) and difference in AUC 0 to four hours between two experimental days was not significant (p = 0.18). On the placebo day eight participants took rescue medication compared to 3 on the sumatriptan day (p = 0.13).CONCLUSION: Despite similarities with migraine headache, cilostazol-induced headache in healthy volunteers does not respond to sumatriptan.

AB - BACKGROUND: A model for the testing of novel antimigraine drugs should ideally use healthy volunteers for ease of recruiting. Cilostazol provokes headache in healthy volunteers with some migraine features such as pulsating pain quality and aggravation by physical activity. Therefore, this headache might respond to sumatriptan, a requirement for validation. The hypothesis of the present study was that sumatriptan but not placebo is effective in cilostazol-induced headache in healthy individuals.METHODS: In a double-blind, randomized, cross-over design, 30 healthy volunteers of both sexes received cilostazol 200 mg on two separate days, each day followed by oral self-administered placebo or sumatriptan 50 mg. Headache response and accompanying symptoms were registered in a questionnaire by the participants themselves.RESULTS: Cilostazol induced a reproducible headache in 90% of the participants. The headache had several migraine-like features in most individuals. Median peak headache score was 2 on the sumatriptan day and 3 on the placebo day (p = 0.17). There was no reduction in headache intensity two hours after sumatriptan (p = 0.97) and difference in AUC 0 to four hours between two experimental days was not significant (p = 0.18). On the placebo day eight participants took rescue medication compared to 3 on the sumatriptan day (p = 0.13).CONCLUSION: Despite similarities with migraine headache, cilostazol-induced headache in healthy volunteers does not respond to sumatriptan.

U2 - 10.1177/0333102415583986

DO - 10.1177/0333102415583986

M3 - Journal article

C2 - 25934317

VL - 36

SP - 172

EP - 178

JO - Cephalalgia

JF - Cephalalgia

SN - 0800-1952

IS - 2

ER -