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Active Treatment for Parkinson's Disease
Phase 1
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
Patients aged 30-90 years, both genders
Patients or care-giver must provide informed consent and be willing and able to comply with study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study 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.
Eligible Conditions
- Parkinson's Disease
- Dementia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognition Improvement by Dementia Severity Rating Scale (DSRS) -
Secondary outcome measures
Change from Baseline in Montreal Cognitive Assessment (MOCA) -
Change from Baseline to the End of the Fixed Dose Period in Neuropsychiatric Inventory (NPI) and Caregiver Distress (NPI-D) -
Change from Baseline to the End of the Fixed Dose Period in Parkinson's Disease Questionnaire-39 (PDQ-39) -
+1 moreOther outcome measures
To compare the effect of ENT-01 on motor and non-motor symptoms of Parkinson's disease including Movement Disorder Society - Unified Parkinsons' Disease Rating Scale (MDS-UPDRS).
To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for skin-temperature determined Circadian rhythm and weight.
To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for weight.
Side effects data
From 2021 Phase 2 trial • 151 Patients • NCT0378179134%
Nausea
19%
Diarrhoea
8%
Abdominal Pail
8%
Dizziness
8%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Treatment
Placebo Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Active TreatmentExperimental Treatment1 Intervention
ENT-01 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
277 Total Patients Enrolled
Michael Zasloff, MD, Ph.DStudy ChairEnterin Inc.
Denise Barbut, MD, FRCPStudy ChairEnterin Inc.
2 Previous Clinical Trials
178 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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