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Completed Phase 2 Interventional Results available

A Study of CNSA-001 in Women With Diabetic Gastroparesis

ClinicalTrials.gov ID: NCT03712124

Public ClinicalTrials.gov record NCT03712124. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 8:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study of CNSA-001 in Women With Moderate to Severe Diabetic Gastroparesis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study evaluates CNSA-001 (sepiapterin) in the treatment of women with moderate to severe diabetic gastroparesis. Participants will be randomized in a ratio of 1:1 to receive CNSA-001 20 (milligrams) mg/kilogram (kg)/day or placebo. All participants will receive the standard of care for diabetic gastroparesis.

Study identification

NCT ID
NCT03712124
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
PTC Therapeutics
Industry
Enrollment
21 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 26, 2019
Primary completion
Sep 7, 2019
Completion
Oct 7, 2019
Last update posted
Jan 4, 2022

2019

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
GW Research, Inc. Chula Vista California 91910
LMG Research Miami Florida 33125
Indiana University Hospital Indianapolis Indiana 46202
University of Louisville Louisville Kentucky 40202
Johns Hopkins University Baltimore Maryland 21224
Clinical Research Solutions, LLC Jackson Tennessee 38305

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03712124, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 4, 2022 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03712124 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →