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NCT03047629 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation
A Phase 1 study of Parkinson's Disease and Constipation, sponsored by Enterin.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 15
- Study locations
NCT03047629: Completed Phase 1 study of Parkinson's Disease and Constipation, sponsored by Enterin.
NCT03047629 is a Phase 1 study of Parkinson's Disease and Constipation that has completed, run by Enterin. The registered enrollment target is 50 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (92% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03047629, a Phase 1 study of Parkinson's Disease and Constipation, has completed, sponsored by Enterin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an orally-administered medication to relieve symptoms of constipation associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be studied over an 8-10 week period. All subjects will receive the study drug during one of the observational periods of the study.
Primary Outcome
Specific treatment related events of recurrent vomiting, recurrent diarrhea, abdominal pain, and hypotension will be assessed with respect to grade and frequency of occurrence.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ENT-01
Study Locations (15)
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- Neuroscience Research, University of Florida Jacksonville - Jacksonville
- MEDSOL Clinical Research - Port Charlotte
- Sarasota Memory Hospital Clinical Research Ctr. - Sarasota
- Suncoast Neuroscience Associates, Inc - St. Petersburg
- USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence - Tampa
Ohio
- Riverhills Healthcare, Inc. - Cincinnati
- Parkinson's & Movement Disorders Center, UH Cleveland Medical Center - Cleveland
Pennsylvania
- Penn State Health, Department of Neurology - Hershey
- Thomas Jefferson University, Department of Neurology - Philadelphia
California
- Keck Hospital of University of Southern California - Los Angeles
Colorado
- Rocky Mountain Movement Disorders Center, PC - Englewood
District of Columbia
- Georgetown Universtiy, Department of Neurology - Washington D.C.
Michigan
- Quest Research Institute - Farmington Hills
New York
- Movement Disorders Division, Mt. Sinai School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2018-06-14 |
| Phase | Phase 1 |
What the finished NCT03047629 record still lists
NCT03047629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03047629 lists 15 locations in 8 states (Florida, Ohio, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03047629 about?
NCT03047629 is a clinical study titled "Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation". This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an orally-administered medication to relieve symptoms of constipation associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be studied over an 8-12 week period. ...
What is the current status of trial NCT03047629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-05-11. Estimated completion is 2018-06-14.
What conditions does trial NCT03047629 study?
This clinical trial studies the following conditions: Parkinson's Disease, Constipation.
What interventions are being tested in trial NCT03047629?
The interventions under investigation include: Placebo (OTHER), ENT-01 (DRUG).
Who is sponsoring clinical trial NCT03047629?
This trial is sponsored by Enterin, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03047629 being conducted?
This trial has 15 study locations across California, Colorado, District of Columbia, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03047629's enrollment target sits among peer trials
50 82nd of 158 higher than 73 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
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