Tenapanor in Synucleinopathy-Related Constipation

Cedar Valley Digestive Health Center

Status and phase: Enrolling; Phase 2

Conditions: Synucleinopathy; Parkinson's Disease

Treatments: Drug: Tenapanor; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06460038

2405-21279

Details and patient eligibility

About

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Full description

Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson's disease.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age 50-89 years.
2. Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
3. 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.
4. Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
5. Agreement to use contraception, if applicable.

Exclusion Criteria

1. Functional diarrhea or IBS-D/M based on Rome IV Criteria.
2. Symptomatic structural GI abnormalities or inflammatory bowel disease.
3. Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine >2mg/dl) dysfunction.
4. Pregnancy or lactation.
5. Diagnosis of primary dyssynergic defecation by anorectal manometry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Tenapanor

Experimental group

Description:

Tenapanor 50 mg orally twice daily for 12 weeks

Treatment:

Drug: Tenapanor

Placebo

Placebo Comparator group

Description:

Placebo orally twice daily for 12 weeks

Treatment:

Drug: Placebo