A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

Phase 3 Completed 630 enrolled Impax Laboratories, LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

Timeline

Start: 2018-11-06
Primary completion: 2021-06-15
Completion: 2021-06-15

Publications

Hauser RA, Espay AJ, Ellenbogen AL, Fernandez HH, Isaacson SH, LeWitt PA, Ondo WG, Pahwa R, Schwarz J, Stocchi F, Zeitlin L, Banisadr G, Fisher S, Visser H, D'Souza R. IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1062-1069. doi: 10.1001/jamaneurol.2023.2679.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levodopa	Small molecule	25 mg	Oral
Subject	Levodopa	Small molecule	37.5 mg	Oral
Subject	Levodopa	Small molecule	50 mg	Oral
Subject	Levodopa	Small molecule	70 mg	Oral
Subject	Levodopa	Small molecule	100 mg	Oral
Subject	Levodopa	Small molecule	105 mg	Oral
Subject	Levodopa	Small molecule	140 mg	Oral
Subject	Levodopa	Small molecule	150 mg	Oral
Subject	Levodopa	Small molecule	175 mg	Oral
Subject	Levodopa	Small molecule	200 mg	Oral
Subject	Levodopa	Small molecule	280 mg	Oral
Subject	Levodopa	Small molecule	420 mg	Oral
Subject	Levodopa	Small molecule	560 mg	Oral
Subject	Levodopa	Small molecule	700 mg	Oral

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

Summary

Timeline

Publications

Drugs

Indications