(HealthDay News) — Oral ENT-01, which inhibits the formation of α-synuclein aggregation, is safe and improves constipation among patients with Parkinson disease (PD) and constipation, according to a study published online Nov. 8 in the Annals of Internal Medicine.
Michael Camilleri, MD, from Mayo Clinic in Rochester, Minnesota, and colleagues examined the safety and efficacy of oral ENT-01 for constipation and neurological symptoms in 150 patients with PD and constipation in a randomized, placebo controlled study. Patients received either ENT-01 or placebo daily for up to 25 days.
The researchers found that the weekly complete spontaneous bowel movement (CSBM) rate increased from 0.7 to 3.2 and from 0.7 to 1.2 in the ENT-01 and placebo groups, respectively. Significant improvements were seen in secondary end points, including SBMs, stool consistency, ease of passage, and laxative use. Among patients with dementia, Mini-Mental State Examination scores improved by 3.4 and 2.0 points at 6 weeks after treatment in the ENT-01 and placebo groups, respectively (14 patients in each group). The Scale for the Assessment of Positive Symptoms adapted for PD scores improved from 6.5 to 1.7 and from 6.3 to 4.4 at 6 weeks after treatment in the ENT-01 and placebo groups, respectively, among patients with psychosis.
ENT-01 was well tolerated; no deaths or drug-related adverse events were reported. Adverse events were mainly gastrointestinal and included nausea and diarrhea.
“We show that orally administered ENT-01 is safe and that it rapidly normalizes bowel function in a dose-dependent fashion, with an effect that seems to persist for several weeks beyond the treatment period,” the authors write.
The study was funded by Enterin, the developer of ENT-01.