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NCT03712124 · ClinicalTrials.gov registry record · Phase 2
A Study of CNSA-001 in Women With Diabetic Gastroparesis
A Phase 2 study, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03712124: Completed Phase 2 study, sponsored by PTC Therapeutics.
NCT03712124 is a Phase 2 study that has completed, run by PTC Therapeutics. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03712124, a Phase 2 study, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Participants consumed 150 milliliters (mL) of Ensure™ every 5 minutes for the nutrient satiety test. At 5-minute intervals, participants scored their fullness using a rating scale that combines verbal descriptors on a scale graded 0 to 5 (0 = no symptoms, 1 = first sensation of fullness \[threshold\], 2 = mild, 3 = moderate, 4 = severe and 5 = maximum or unbearable fullness). Participants were told to stop when a score of 5 was obtained. The actual volume of Ensure™ consumed at this point was th
Interventions
- DRUG Placebo
- DRUG CNSA-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2019-10-08 |
| Phase | Phase 2 |
What the finished NCT03712124 record still lists
NCT03712124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03712124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03712124 about?
NCT03712124 is a clinical study titled "A Study of CNSA-001 in Women With Diabetic Gastroparesis". 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...
What is the current status of trial NCT03712124?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2019-02-27. Estimated completion is 2019-10-08.
What interventions are being tested in trial NCT03712124?
The interventions under investigation include: Placebo (DRUG), CNSA-001 (DRUG).
Who is sponsoring clinical trial NCT03712124?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03712124's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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