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Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)

NCT03781791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2024-02-20

Study results available
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Summary

This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo.

\- Study Update-

Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.

Conditions

Interventions

DRUG

Active Investigational Treatment ENT-01

ENT-01 will be administered in tablet form, once daily.

DRUG

Placebo Treatment

Placebo will be administered in tablet form, once daily.

Sponsors & Collaborators

  • Enterin Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Zasloff, MD PhD · Enterin Inc.

  • Denise Barbut, MD, FRCP · Enterin Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781791 on ClinicalTrials.gov