Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 72
Summary
- Conditions
- Constipation
- Parkinson Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 90 years
- Gender
- Both males and females
Description
The study will be conducted on an out-patient basis. Each patient will have 6 visits to the clinic: a screening visit, a randomization visit, 3 follow up visits, and 1 end of study visit. Patient randomization will be stratified based upon the baseline weekly complete spontaneous bowel movement rate...
The study will be conducted on an out-patient basis. Each patient will have 6 visits to the clinic: a screening visit, a randomization visit, 3 follow up visits, and 1 end of study visit. Patient randomization will be stratified based upon the baseline weekly complete spontaneous bowel movement rate (CSBM) established during the screening period. 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. Patients will also be asked to participate in up to 2 sub-studies: a pk study and/or a stool microbiome study. The first 20 patients to consent to the pk study will have additional blood samples taken at randomization and at 2 follow up visits. The first 20 patients to consent to the stool microbiome study will provide stool samples at randomization and at 2 follow up visits.
Tracking Information
- NCT #
- NCT03781791
- Collaborators
- Not Provided
- Investigators
- Study Chair: Michael Zasloff, MD PhD Enterin Inc. Study Director: Denise Barbut, MD, FRCP Enterin Inc.
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