Ongoing Phase 2b Study in Parkinson’s Disease
A Multicenter, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson’s Disease Related Constipation (KARMET). Neurologic symptoms will also be evaluated. The study has been published on ClinicalTrials.gov under the title ‘Orally Administered ENT-01 for Parkinson’s Disease-Related Constipation (KARMET)’ and ClinicalTrials.gov Identifier NCT03781791. The study began in December 2018 and will be conducted at up to 35 sites across the country. Seventy two (72) patients with Parkinson’s Disease and constipation will be included in a study that will require 5 visits over a period of 4 months. For further information, please go to ClinicalTrials.gov or The Michael J. Fox Foundation.
Enterin is looking for patients with Parkinson’s Disease who also suffer from constipation. If you’re interested in learning more about participating in the KARMET study, please reach out to the most convenient clinical study site to determine if you qualify.
In order to qualify for this study, patients must meet certain requirements, known as inclusion criteria. Some key inclusion criteria include the following:
- The participant must be 30-86 years old;
- The participant must have been diagnosed with Parkinson’s Disease, defined as the presence of at least three of the following features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities;
- The participant must have had constipation for over 6 months and be unresponsive to over the counter treatments such as Milk of Magnesia, MiraLAX or the equivalent, taken at least once weekly with an inconsistent response over a 6-week period, or is dissatisfied with other first line treatments;
- The participant must have fewer than 3 bowel movements per week if laxatives are not used; and
- The participant can provide written informed consent and is willing and able to comply with study procedures.
Please click the button below to search for clinical trial sites near you. Both an email address and telephone number are provided so that you may contact your preferred site to learn more about participating in the KARMET study. If you cannot locate a site that is convenient for you, please return periodically, as we will be adding new sites as they become active in the KARMET study.