Attenuated Postprandial GLP-1 Response in Parkinson's Disease.
Richard A Manfready, Phillip A Engen, Leo Verhagen Metman...
https://pubmed.ncbi.nlm.nih.gov/34276285Actively Recruiting
Phase 2
Age: 50Years - 89Years
All Genders
ID06460038
Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Led by Cedar Valley Digestive Health Center · Updated on 2025-02-10
30
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
C
Cedar Valley Digestive Health Center
Lead Sponsor
A
Ardelyx
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating tenapanor, an inhibitor of NHE3, as a potential treatment for constipation associated with synucleinopathy in Parkinson's disease. This randomized, double-blind, placebo-controlled Phase 2 trial aims to assess the efficacy and safety of tenapanor compared to placebo in adults with Parkinson's disease experiencing constipation. The study is sponsored by Cedar Valley Digestive Health Center and focuses on improving bowel movement frequency and related symptoms. Participants will be randomly assigned to receive either tenapanor 50 mg or a placebo, both taken orally twice daily for 12 weeks. The trial includes a 12-week treatment period where the effects of the drug on constipation symptoms will be compared to placebo. The study monitors multiple outcomes including complete spontaneous bowel movements, abdominal pain, bloating, and various biomarkers. During the study, participants will undergo assessments of their bowel movements and symptom responses at 6 and 12 weeks. Researchers will also collect blood samples to measure inflammatory and gut barrier markers. The primary outcome is the number of complete spontaneous bowel movements during 6 of the 12 weeks. Safety, tolerability, and secondary outcomes like abdominal symptoms and biomarker levels will be measured. Participants will be followed for the 12-week treatment period, with regular monitoring and evaluations.
CONDITIONS
Brief Title
Tenapanor in Synucleinopathy-Related Constipation
Who Can Participate
Age: 50Years - 89Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 50 to 89 years
- Diagnosis of Parkinson's disease within Hoehn and Yahr stages 1-3 confirmed by a neurologist
- Average weekly stool frequency of 5 or fewer spontaneous bowel movements and 2 or fewer complete spontaneous bowel movements over the past 6 months
- Stool consistency 3 or less on the Bristol Stool Form Scale
- Agreement to use contraception, if applicable
You will not qualify if you...
- Functional diarrhea or IBS-D/M based on Rome IV Criteria
- Symptomatic structural gastrointestinal abnormalities or inflammatory bowel disease
- Significant liver dysfunction (ALT or AST 2.5 times the upper limit of normal or higher) or kidney dysfunction (serum creatinine greater than 2 mg/dl)
- Pregnancy or lactation
- Diagnosis of primary dyssynergic defecation by anorectal manometry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take Tenapanor or placebo orally twice daily to treat constipation related to synucleinopathy in Parkinson's disease.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Cedar Valley Digestive Health Center
Waterloo, Iowa, United States, 50701
Actively Recruiting
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Research Team
R
Richard A. Manfready, MD, AM, FACP
H
Harichandana Punukula, PharmD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Gut-Brain Communication in Parkinson's Disease: Enteroendocrine Regulation by GLP-1.
Richard A Manfready, Christopher B Forsyth, Robin M Voigt...
https://pubmed.ncbi.nlm.nih.gov/35633466Overview of the Gut-Brain Axis: From Gut to Brain and Back Again.
Zoë Post, Richard A Manfready, Ali Keshavarzian
https://pubmed.ncbi.nlm.nih.gov/37562457An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants.
Deborah A Hall, Robin M Voigt, Thaisa M Cantu-Jungles...
https://pubmed.ncbi.nlm.nih.gov/36801916Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial.
William D Chey, Anthony J Lembo, David P Rosenbaum
https://pubmed.ncbi.nlm.nih.gov/28244495Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).
William D Chey, Anthony J Lembo, Yang Yang...
https://pubmed.ncbi.nlm.nih.gov/33337659Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).
William D Chey, Anthony J Lembo, David P Rosenbaum
https://pubmed.ncbi.nlm.nih.gov/31934897