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Table 2 Primary and secondary endpoints

From: Galcanezumab in episodic migraine: the phase 3, randomized, double-blind, placebo-controlled PERSIST study

Endpoint

Time frame

LS Mean Change (SE)

LS Mean Change Difference / Odds Ratio (95% CI)

p-value

Galcanezumab 120 mg

Placebo

Monthly MHDs

Month 1–3

-3.81 (0.23)

-1.99 (0.23)

-1.82 (-2.32, -1.32)a

 < 0.0001

 ≥ 50% response rate

Month 1–3

54.9 (2.4)b

32.9 (2.3)b

2.48 (1.87, 3.29)c

 < 0.0001

MSQ-RFR

Month 1–3

21.01 (0.85)

13.94 (0.88)

7.07 (5.20, 8.95)a

 < 0.0001

 ≥ 75% response rate

Month 1–3

29.2 (2.1)b

12.7 (1.6)b

2.82 (2.01, 3.97)c

 < 0.0001

100% response rate

Month 1–3

11.9 (1.4)b

3.9 (0.9)b

3.31 (1.99, 5.50)c

 < 0.0001

Monthly MHDs treated with acute medication

Month 1–3

-2.49 (0.22)

-0.71 (0.22)

-1.78 (-2.25, -1.31)a

 < 0.0001

MSQ-Total Score

Month 1–3

19.73 (0.81)

13.56 (0.84)

6.17 (4.39, 7.95)a

 < 0.0001

MSQ-RFP

Month 1–3

18.79 (0.87)

12.76 (0.90)

6.03 (4.10, 7.95)a

 < 0.0001

MSQ-EF

Month 1–3

17.88 (0.98)

13.72 (1.02)

4.16 (2.00, 6.32)a

0.0002

PGI-S

Month 3

-0.83 (0.09)

-0.61 (0.10)

-0.22 (-0.43, -0.02)a

0.0284

MIDAS Total Score

Month 3

-22.61 (2.96)

-10.18 (3.06)

-12.43 (-18.81, -6.05)a

0.0001

  1. aLS mean change difference
  2. bModel estimated rate
  3. cOdds ratio
  4. CI Confidence interval, LS Least squares, MHD Migraine headache day, MIDAS Migraine Disability Assessment, MSQ-EF Migraine Specific Quality of Life Questionnaire Emotional Function, MSQ-RFP Migraine Specific Quality of Life Questionnaire Role Function-Preventive, MSQ-RFR Migraine Specific Quality of Life Questionnaire Role Function-Restrictive, PGI-S Patient Global Impression of Severity, SE Standard error