Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 89
Healthy Volunteers: f
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• Age 50-89 years.
• Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
• Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.
• Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
• Agreement to use contraception, if applicable.
Locations
United States
Iowa
Cedar Valley Digestive Health Center
RECRUITING
Waterloo
Contact Information
Primary
Richard A. Manfready, MD, AM, FACP
rman@alum.mit.edu
(319) 235-5390
Backup
Harichandana Punukula, PharmD, MS
hpunukula@cvmspc.com
319-888-8270
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 30
Treatments
Experimental: Tenapanor
Tenapanor 50 mg orally twice daily for 12 weeks
Placebo_comparator: Placebo
Placebo orally twice daily for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Cedar Valley Digestive Health Center
Collaborators: Ardelyx