A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

Summary

This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com

Timeline

Start

2023-05-15

Primary completion

2024-10-25

Completion

2025-09-13

Publications

• Werner MH, McGarry A, Meyer C, Mancino E, Klint C, Pellecchia J, Kieburtz K, Levine T, Bellaire B, Gibbons C, Freeman R, Ellenbogen A, Klos K, Ospina M, Hauser RA, Shannon K, Asaad H, Park A, McAllister P, Isaacson SH, LeDoux MS, Dhall R, Shpiner D, Charles P, Agarwal P, Peckham E, Mazzeo P, Davis M, Pahwa R, Brodsky M, Lew M, Purino L, Mantri S, Parashos S, Justiz W, Chachar M, Robottom B, Budman E, Blindauer K, Bellows S, Goudreau J, Steen S, Olanow CW. The 201 Trial: a placebo-controlled randomized phase 2 study of safety and tolerance of the c-Abl kinase inhibitor risvodetinib in untreated Parkinson's disease. Nat Aging. 2026 Mar;6(3):626-635. doi: 10.1038/s43587-026-01084-4. Epub 2026 Feb 20.

Drugs

Indications