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Active Treatment for Parkinson's Disease (KARMET Trial)

Phase 2
Waitlist Available
Research Sponsored by Enterin Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 day treatment period, part of which is at a fixed dose.

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.

Eligible Conditions
  • Parkinson's Disease
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 day treatment period, part of which is at a fixed dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 day treatment period, part of which is at a fixed dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Baseline Weekly CSBM-Primary Efficacy Endpoint
The Number of Participants Who Experience Dose Limiting Toxicity Adverse Events
The Number of Participants Who Experience Treatment Related Adverse Events-Safety Endpoint
Secondary study objectives
Change in participant constipation severity from baseline-Secondary Efficacy Endpoints
Other study objectives
Change in baseline stool Microbiome - Exploratory Outcome

Side effects data

From 2021 Phase 2 trial • 151 Patients • NCT03781791
34%
Nausea
19%
Diarrhoea
8%
Dizziness
8%
Vomiting
8%
Abdominal Pail
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Treatment
Placebo Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment1 Intervention
ENT-01 tablet will be taken once daily by mouth.
Group II: Placebo TreatmentPlacebo Group1 Intervention
Placebo tablet will be taken once daily by mouth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Investigational Treatment ENT-01
2018
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Enterin Inc.Lead Sponsor
4 Previous Clinical Trials
126 Total Patients Enrolled
Denise Barbut, MD, FRCPStudy DirectorEnterin Inc.
2 Previous Clinical Trials
27 Total Patients Enrolled
Michael Zasloff, MD PhDStudy ChairEnterin Inc.
~22 spots leftby Oct 2025
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