Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET) (KARMET)
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|ClinicalTrials.gov Identifier: NCT03781791|
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : January 6, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Constipation Parkinson Disease||Drug: Active Investigational Treatment ENT-01 Drug: Placebo Treatment||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)|
|Actual Study Start Date :||December 10, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Active Treatment
ENT-01 tablet will be taken once daily by mouth.
Drug: Active Investigational Treatment ENT-01
ENT-01 will be administered in tablet form, once daily.
Other Name: ENT-01
Placebo Comparator: Placebo Treatment
Placebo tablet will be taken once daily by mouth.
Drug: Placebo Treatment
Placebo will be administered in tablet form, once daily.
- Incidence of Treatment Related Adverse Events-Safety Endpoint [ Time Frame: Through Study treatment up to 10 weeks ]The number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
- Incidence of Treatment Related Adverse Event-Tolerability Endpoints [ Time Frame: Through Study treatment Dosing Period up to 10 weeks ]The number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
- Change in baseline weekly CSBM-Primary Efficacy Endpoint [ Time Frame: Through Study Treatment Dosing Period up to 10 weeks ]Change from participant's weekly CSBM baseline rate during treatment fixed Dose period.
- Change in participant constipation severity from baseline-Secondary Efficacy Endpoints [ Time Frame: Through Study Treatment Dosing Period up to 10 weeks ]Participant reported change from baseline as assessed according to Bristol Stool rating scale (0-5) of increasing severity of ease of bowel evacuation.
- Change in baseline stool Microbiome - Exploratory Outcome [ Time Frame: Through Study Treatment Dosing Period and Completion up to 24 weeks ]Collection of participant baseline intestinal microbiome condition as observed in stool to on treatment related effect of ENT-01 on stool microbiome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781791
|Contact: Denise Barbut, MD, FRCP||215 634 9243||KARMETinfo@enterininc.com|
|Study Chair:||Michael Zasloff, MD PhD||Enterin Inc.|
|Study Director:||Denise Barbut, MD, FRCP||Enterin Inc.|