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Tfelt-Hansen P, Diener HC. Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation. Cephalalgia. 2020;41(2):148-155doi: 10.1177/0333102420956916.
Tfelt-Hansen, P., & Diener, H. C. (2021). Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation. Cephalalgia : an international journal of headache, 41(2), 148-155. https://doi.org/10.1177/0333102420956916
Tfelt-Hansen, Peer, and Diener, Hans-Christoph. "Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation." Cephalalgia : an international journal of headache vol. 41,2 (2021): 148-155. doi: https://doi.org/10.1177/0333102420956916
Tfelt-Hansen P, Diener HC. Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation. Cephalalgia. 2021 Feb;41(2):148-155. doi: 10.1177/0333102420956916. Epub 2020 Sep 09. PMID: 32903063.
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Cephalalgia. 2021 Feb;41(2):148-155. doi: 10.1177/0333102420956916. Epub 2020 Sep 09.

Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation.

Cephalalgia : an international journal of headache

Peer Tfelt-Hansen, Hans-Christoph Diener

Affiliations

  1. Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.
  2. Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany.

PMID: 32903063 DOI: 10.1177/0333102420956916

Abstract

BACKGROUND: Migraine patients want acute treatment to provide complete relief of the migraine attack within 30 minutes. Traditionally, "speed of onset of effect" is evaluated by estimating the time-point for first statistical separation of drug and placebo. The estimated onset of effect can be a few percent difference of patients being pain free in very large randomised, controlled trials. This difference, however, can be clinically irrelevant.

METHODS: Placebo-controlled randomised, controlled trials with pain freedom results from 30 min to 2-4 hours were retrieved from the literature. For each time-point, the therapeutic gain (drug minus placebo) (TG) was calculated. Therapeutic gain for being pain free of 5% was chosen for the definition of "onset of action", since this is approximately 1/3 of the 16% TG and 1/4 of 21% of TG for sumatriptan 50 mg and 100 mg, respectively.

RESULTS: A total of 22 time-effect curves based on randomised, controlled trials were analysed. Based on the "onset of action" of 5% pain freedom, the evaluated drugs and administration forms can be classified as follows: i) Early time to onset, ≤30 min (three randomised, controlled trials); ii) medium time to onset, 60 min (nine randomised, controlled trials); iii) delayed time to onset, 90-120 min (10 randomised, controlled trials).

CONCLUSION: Only three non-oral administration forms with a triptan (subcutaneous sumatriptan and nasal zolmitriptan) resulted in an "onset of action" at ≥30 min; in the future, early onset of action should be a priority in the development of new drugs or new administration-forms for the treatment of acute migraine attacks.

Keywords: Migraine; clinical trials; gepants; lasmiditan; onset of action; triptans

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