A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes

Phase 2 Completed 48 enrolled Sumitomo Pharma America, Inc.

RandomizedCrossoverQuadruple-blindTreatment

Summary

A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Timeline

Start: 2017-08-03
Primary completion: 2017-12-21
Completion: 2017-12-21

Outcome

Met primary endpoint

paper Upper limits of 90% confidence intervals (CIs) for ΔΔQTcF of SL-APO were below the 10-millisecond regulatory threshold at all prespecified timepoints, demonstrating no clinically significant effect on QTcF. PMID 35899977 ↗

Publications

Stocchi F, Peckham EL, De Pandis MF, Sciarappa K, Kleiman R, Agbo F, Olanow CW, Blum D, Navia B. A Randomized Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson's Disease. Clin Pharmacol Drug Dev. 2022 Sep;11(9):1068-1077. doi: 10.1002/cpdd.1147. Epub 2022 Jul 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apomorphine	Unknown	—	—
Comparator	Moxifloxacin	Small molecule	400 mg	—