NCT03938922

A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia

A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Enterin Inc. · Industry
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted as a multi-center, open label study in the US. There will be 40 patient to receive the active investigational product.

Detailed description

The study will be conducted on an out-patient basis. Each patient will have 5 visits to the clinic: a screening visit, a randomization visit, 1 followup visit, 1 end of treatment visit, and 1 end of study visit. Patients will be allowed to adjust their dosing, based upon protocol specifications. Rescue medications will be provided to all patients to ensure they move their bowels on a regular basis.

Conditions

• Parkinson Disease
• Dementia

Interventions

Type	Name	Description
DRUG	Active Investigational Treatment ENT-01	ENT-01 will be administered in tablet form, once daily. Other Names: ENT-01

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-06-15
• Completion: 2025-12-15
• First posted: 2019-05-06
• Last updated: 2024-03-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study