Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America

Rigmor Hoejland Jensen, Cristina Tassorelli, Tina M. Myers Oakes, Jennifer N. Bardos, Chunmei Zhou, Yan Dong, Sheena K. Aurora, James M. Martinez*

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Abstract

Objective: Two phase 3 galcanezumab trials were conducted in Europe and North America to analyze the reduction of weekly cluster headache (CH) attack frequency in populations with episodic and chronic CH. The current study aims to illustrate prospectively recorded baseline clinical data from these trials and to identify possible predictors of response.

Methods: Patients (aged 18–65 years) met The International Classification of Headache Disorders 3rd edition-beta criteria for CH. Attacks were evaluated using an electronic headache diary for 7-day (episodic) or 14-day (chronic) eligibility assessments before patients were randomized 1:1 to monthly subcutaneous galcanezumab 300 mg or placebo.

Results: Data were collected from 106 patients with episodic and 237 with chronic CH. Overall, the mean age [standard deviation] was 45.4 [11.0] years; patients were predominantly White (84.5%), male (75.8%), and European (77.6%). Patients with episodic CH reported 17.5 [10.0] attacks/week; patients with chronic CH reported 18.8 [10.2] attacks/week. The average pain severity score (range 0–4) was 2.5 [0.7] for episodic CH and 2.7 [0.7] for chronic CH. Higher attack frequency was a possible predictor of response to galcanezumab; potential negative predictors of response were greater attack severity and duration.

Conclusion: This large dataset of patients with CH provides reliable systematically and prospectively collected information on disease characteristics. The analysis in episodic CH underscores potential predictors of response worth considering for future CH trial design.
OriginalsprogEngelsk
Artikelnummer1293163
TidsskriftFrontiers in Neurology
Vol/bind14
Antal sider11
ISSN1664-2295
DOI
StatusUdgivet - 2023
Udgivet eksterntJa

Bibliografisk note

Funding Information:
The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study received funding from Eli Lilly and Company. The funder had the following involvement with the study: Eli Lilly and Company sponsored both studies (trial registration numbers: NCT02438826 and NCT02397473) referenced in this publication.

Funding Information:
The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study received funding from Eli Lilly and Company. The funder had the following involvement with the study: Eli Lilly and Company sponsored both studies (trial registration numbers: NCT02438826 and NCT02397473) referenced in this publication.

Publisher Copyright:
Copyright © 2023 Jensen, Tassorelli, Myers Oakes, Bardos, Zhou, Dong, Aurora and Martinez.

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