What the trial was testing
The KARMET enrolled 151 patients with parkinson's disease. The study was sponsored by Enterin Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People on ENT-01 went from less than 1 bowel movement per week to more than 3 per week.
Annals of internal medicine · 2022 · NCT03781791
These findings — that up from less than 1 per week before treatment — were published in the Annals of internal medicine and represent the headline result of the study.
Researchers tracked outcomes across 151 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with parkinson's disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an early-stage study and ENT-01 is not yet FDA-approved. The treatment was well-tolerated with mainly nausea and diarrhea as side effects. If you have Parkinson's and struggle with constipation, ask your doctor about open trials testing ENT-01 or other options to manage this symptom.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open parkinson's disease trials
Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.
Home-based Gait and Balance Training in Patients With Movement Disorders
The research project is an experimental study with three study visits at the study site at the University Hospital Düsseldorf (UKD) / Heinrich Heine University Düsseldorf (HHU) and a three-week training phase in a parallel design. Patients with movement disorders (ataxia or Parkinson\'s disease) can take part. The training phase includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. Two different training protocols are carried out in parallel for three weeks each: One with 20 minutes of training per day, four days per week; and one with a training duration of 40 minutes per day, only two days per week. All patients initially take part in a one-week familiarization phase without training and are then randomly assigned to one of the two training protocols or the control group without additional training. In both training phases, the total amount of weekly training time is the same, but the frequency and duration of training sessions per week differs. The patients who were assigned to the control group without additional training can complete the training after their third study visit.