Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease

Phase 3 Completed 141 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.

Timeline

Start: 2015-06-18
Primary completion: 2017-12-11
Completion: 2017-12-11

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo (Maintenance) vs APL-130277 (Maintenance); p = 0.0002; LS mean differnce -7.6 (95% CI -11.5 to -3.7) NCT02469090 ↗

paper with apomorphine sublingual film and -3·5 (1·29, -6·1 to -0·9) with placebo (difference -7·6, SE 1·96, 95% CI -11·5 to -3·7; p=0·0002). PMID 31818699 ↗

Publications

Olanow CW, Factor SA, Espay AJ, Hauser RA, Shill HA, Isaacson S, Pahwa R, Leinonen M, Bhargava P, Sciarappa K, Navia B, Blum D; CTH-300 Study investigators. Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study. Lancet Neurol. 2020 Feb;19(2):135-144. doi: 10.1016/S1474-4422(19)30396-5. Epub 2019 Dec 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apomorphine	Unknown	10 mg	Other
Subject	Apomorphine	Unknown	15 mg	Other
Subject	Apomorphine	Unknown	20 mg	Other
Subject	Apomorphine	Unknown	25 mg	Other
Subject	Apomorphine	Unknown	30 mg	Other
Subject	Apomorphine	Unknown	35 mg	Other