Emgality® (Galcanezumab)

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Galcanezumab: Migraine and Headache Endpoint Definitions

Migraine and headache endpoint definitions applied in the galcanezumab phase 3 migraine prevention studies are provided below.


The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country. 

Clinical Trial Information

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2)1,2
  • chronic migraine (REGAIN),3 and
  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).4

The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days over

  • 6 months for the EVOLVE-1 and EVOLVE-2 studies,1,2 and
  • 3 months for the REGAIN and CONQUER studies.3,4

Headache Endpoint Definitions

Headache Endpoint Definitions in Galcanezumab Phase 3 Migraine-Prevention Studies5


Was defined as...

Migraine headache daya

a calendar day on which a migraine headache or probable migraine headache occurred.

Non-migraine headache day

a calendar day on which a non-migraine headache occurred.

Headache day

a calendar day on which any type of headache occurred including

  • migraine headache
  • probable migraine headache, and
  • non-migraine headache.

aPrimary objective.

Migraine and Headache Definitions

Migraine and Headache Definitions in Galcanezumab Phase 3 Migraine-Prevention Studies5,6


Was defined as...

Migraine headachea

a headache

  • with or without aura
  • of ≥30 minutes duration 
  • with required features in criteria A and B, or
  • meets criterion C.b

Criteria A: at least 2 of the following characteristics

  • unilateral location
  • pulsatile quality
  • moderate or severe pain intensity, or
  • aggravation by or causing avoidance of routine physical activity.

Criteria B: at least one of the following characteristics during the headache

  • nausea with or without vomiting, or
  • photophobia and phonophobia.

Criterion C: the headache is believed by the patient to be migraine at onset and is relieved by a triptan or ergot derivative.b

Probable migraine

a headache missing one of the migraine features in the IHS ICHD-3 beta definition such as

  • missing 1 feature in criteria A
  • missing 1 feature in criteria B, or
  • meeting criteria A and not criteria B.

It must not meet criterion C.b

Migraine headache attack

  • beginning on any day a migraine headache or probable migraine headache is recorded, and
  • ends when a migraine-free day occurs.

Non-migraine headache

all headaches

  • of ≥30 minutes duration, and
  • not fulfilling the definition of migraine or probable migraine.

Abbreviation: IHS ICHD-3 beta = International Headache Society International Classification of Headache Disorders – 3rd edition, beta.

aDefinition adapted from the Standard IHS ICHD-3 beta.

bCriterion C only applied to the chronic migraine prevention study, REGAIN.


1Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212

2Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

3Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640

4Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

6Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808. http://dx.doi.org/10.1177/0333102413485658

Fecha de la última revisión: 2020 M10 05

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