Recruiting PHASE2 Synucleinopathy

Clinical trial for Synucleinopathy

Official title Tenapanor in Synucleinopathy-Related Constipation

ClinicalTrials.gov ID: NCT06460038

What this study is testing

What is Tenapanor?

Tenapanor is an investigational medicine, being studied as a potential treatment for synucleinopathy.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 to 89

You may be able to join if

  • 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...
  • 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.

You likely can't join if

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

The study team makes the final eligibility decision.

Where it's taking place

  • Waterloo, Iowa, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 50 years to 89 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Waterloo, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.