Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Peer Tfelt-Hansen; Karsten Jørgensen; Hans-Christoph Diener

doi:10.1177/03331024211029939

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Peer Tfelt-Hansen^*, Karsten Jørgensen, Hans-Christoph Diener

^*Corresponding author for this work

Department of Neurology

Abstract

PURPOSE: In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo.

CONCLUSION: To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with "scientific rigor" in the second step of these trials, and this design is not recommended.

Original language	English
Journal	Cephalalgia : an international journal of headache
Volume	42
Issue number	1
Pages (from-to)	82-85
Number of pages	4
ISSN	0333-1024
DOIs	https://doi.org/10.1177/03331024211029939
Publication status	Published - Jan 2022

Keywords

lasmiditan
Placebo
ubrogepant

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10.1177/03331024211029939

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Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks. / Tfelt-Hansen, Peer; Jørgensen, Karsten; Diener, Hans-Christoph.
In: Cephalalgia : an international journal of headache, Vol. 42, No. 1, 01.2022, p. 82-85.

Research output: Contribution to journal › Journal article › Research › peer-review

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N2 - PURPOSE: In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo.CONCLUSION: To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with "scientific rigor" in the second step of these trials, and this design is not recommended.

AB - PURPOSE: In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo.CONCLUSION: To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with "scientific rigor" in the second step of these trials, and this design is not recommended.

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Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

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Keywords

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