A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease

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The research company Inhibikase Therapeutics, Inc is conducting A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease.

This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (55 to 75 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.

It is planned to include 120 participants.

Actual study start date is May 23, 2022. The researchers expect to complete the study by October 31, 2023.

One primary outcome measure is Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention.

Further details can be found here https://ichgcp.net/clinical-trials-registry/NCT05424276 or https://clinicaltrials.gov/ct2/show/NCT05424276.

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