NCT02438215

Study of IRX4204 for Treatment of Early Parkinson's Disease

An Open-Label, Single Site Study Using [123I]β-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Io Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single site, open-label study designed to examine dopamine transporter density using \[123I\]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day period in early Parkinson's disease patients. In addition, clinical evaluations will be performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of PD.

Detailed description

Fifteen patients with early PD were enrolled in this open label study, in 3 cohorts of 5 patients each, treated with IRX4204 at 5 mg/day, 10mg/day, or 20 mg/day. Patients were administered IRX4204 orally once daily. Baseline assessments were performed for total motor score, and Unified Parkinson's Disease Rating Scale (UPDRS). Follow-up assessments of these clinical outcome measures were performed at 14 and 29 days of treatment. \[123\]β-CIT SPECT imaging for assessment of dopamine active transporter (DAT) expression was performed at baseline, and on day 30 of IRX4204 treatment. Patients had clinical hematology and chemistry laboratory tests, and recording of adverse events, performed at baseline and at follow up visits.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	IRX4204	IRX4204 is a potent and highly selective orally available and brain penetrant RXR nuclear receptor agonist small compound administered as gel capsules.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-05-08
• Last updated: 2015-05-12

Locations

1 site across 1 country: United States