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Phase 3 Clinical Trial Information
Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of
Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine.4
Patients in the phase 3 migraine program were reflective of the migraine patient population with regard to demographics, disease characteristics, and comorbid medical conditions, including depression, anxiety, insomnia, and pain.5,6
Inclusion in Phase 3 Clinical Trials
Patients with major depressive disorder or generalized anxiety disorder whose disease state was considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, were considered for inclusion if they were not on excluded medications.6
Because depression and anxiety are relatively common in people with migraine, this provision ensured that with respect to presence of concomitant depression/anxiety, the patient population would be similar to that seen in clinical practice.6
In the galcanezumab phase 3, randomized, double-blind, placebo-controlled studies for the prevention of migraine (EVOLVE-1, EVOLVE-2, REGAIN), 11.4% of patients had pre-existing anxiety, and 11.9% had pre-existing depression.6 Subgroup analysis of this population was not done.
Exclusion in Phase 3 Clinical Trials
Clinical trial exclusion criteria included evidence of significant active or unstable psychiatric disease by medical history, such as
personality disorders, or
other serious mood or anxiety disorders.6
Patients were excluded if
in the clinician’s judgment, they were actively suicidal and therefore deemed to be at significant risk for suicide, or
answered “yes” to any of the items in Table 1, and
the ideation or behavior occurred within the past month.6
Table 1. Select Columbia Suicide Severity Rating Scale Items6
4 - Active suicidal ideation with some intent to act, without
Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.7
The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.7
1. Stauffer 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
2. Skljarevski 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
3. Detke 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
4. Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurology. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2
5. Buse DC, Rupnow MFT, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84(5):422-435. http://dx.doi.org/10.1016/S0025-6196(11)60561-2
7. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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