Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study

• Published in: Neurology and therapy 2021-06, Vol.10 (1), p.265-278
• Main Authors: Tatsuoka, Yoshihisa, Takeshima, Takao, Ozeki, Akichika, Matsumura, Taka
• Format: Article
• Language: English
• Subjects: Internal Medicine; Medicine; Medicine & Public Health; NCT; NCT02959177; Neurology; Original Research
• ISSN: 2193-8253; 2193-6536
• DOI: 10.1007/s40120-021-00236-5

Introduction This analysis evaluated the treatment satisfaction of Japanese patients receiving galcanezumab (GMB) as a preventive medication for episodic migraine (4–14 monthly migraine headache days). Methods This phase 2, randomized, double-blind, placebo-controlled study enrolled patients aged 18–65 years at 40 centers in Japan. Patients were randomized 2:1:1 to receive monthly subcutaneous injections of placebo (PBO, n  = 230), GMB 120 mg ( n  = 115), or GMB 240 mg ( n  = 114) for 6 months. Patients’ experience with treatment was measured using the Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) scales. PGI-S was administered at baseline and months 1–6, PGI-I at months 1–6, and PSMQ-M at months 1 and 6. Prespecified analyses were differences between GMB and PBO in PGI-I and the change from baseline in PGI-S, and evaluating positive responses for the PGI-I and PSMQ-M. Results Average change ± SE from baseline across months 1–6 was − 0.09 ± 0.05 (PBO), − 0.17 ± 0.07 (GMB 120 mg, p  = 0.33), and − 0.30 ± 0.07 (GMB 240 mg, p  = 0.013) for PGI-S. Average PGI-I across months 1–6 was 3.39 ± 0.05 (PBO), 2.55 ± 0.07 (GMB 120 mg, p