At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with PD consistent with UK Brain Bank and MDS Research Criteria, including bradykinesia with sequence effect and motor asymmetry
- ✓No prior anti-parkinsonian therapy
- ✓Modified Hoehn/Yahr Stage less than 3.0
- ✓Montreal Cognitive Assessment score of 24 or higher
- ✕Diagnosis or suspicion of secondary or atypical parkinsonism
- ✕Previous or anticipated PD surgery/procedures during study
- ✕High likelihood of needing anti-parkinsonian treatment during study period
- ✕Clinically significant orthostatic hypotension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease
In Brief
A Phase 2 clinical trial evaluating IkT-148009 (risvodetinib) and Placebo for Parkinson Disease. Completed, enrolled 137 participants across 28 sites.
Detailed 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
Study Details
Timeline
Interventions
Oral administration gelatin capsule
Oral administration gelatin capsule