TABLE 3.

Efficacy Results From SPAN-PD Study

Efficacy Outcome	Hierarchical Step	Measure of Difference	Levodopa Inhalation Powder vs Placebo (95% CI)	P
Levodopa inhalation powder 84 mg vs placebo
Change in UPDRS motor score at 30 min	1	LS mean difference	−3.92 (−6.84 to −1.00)	0.0088
Achieve and maintain ON state at 60 min postdose	2	OR	2.65 (1.48 to 4.76)	0.0027
Change in UPDRS motor score at 20 min	3	LS mean difference	−2.55 (−5.22 to 0.13)	0.062*
Improvement on PGIC	4	OR	2.94 (1.62 to 5.33)	<0.001*
Change in UPDRS motor score at 10 min	5	LS mean difference	−2.26 (−4.48 to −0.04)	0.046*
Change in time spent in OFF state, per PD diary	6	LS mean difference	−0.01 (−0.55 to 0.56)	0.975*
Levodopa inhalation powder 60 mg vs placebo
Change in UPDRS motor score at 30 min	7	LS mean difference	−3.07 (−5.99 to −0.16)	0.039*
Achieve and maintain ON state at 60 min postdose	8	OR	2.30 (1.29 to 4.10)	0.006*
Change in UPDRS motor score at 20 min	9	LS mean difference	−1.98 (−4.65 to 0.70)	0.147*
Improvement on PGIC	10	OR	1.85 (1.05 to 3.28)	0.026*
Change in UPDRS motor score at 10 min	11	LS mean difference	−0.97 (−3.19 to 1.24)	0.387*
Change in time spent in OFF state, per PD diary	12	LS mean difference	−0.10 (−0.66 to 0.46)	0.722*

Reprinted from LeWitt PA, Hauser RA, Pahwa R, et al.³⁹ Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol 2019;18(2):145–154. Used with permission.

*Because the P value for hierarchical step 3 (change in UPDRS motor score at 20 minutes) did not reach statistical significance, all subsequent P values (steps 4–12) are nominal only

LS, least squares; OR, odds ratio; PGIC, Patient Global Impression of Change; UPDRS, Unified Parkinson's Disease Rating Scale.