At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
CNSA-001 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study of CNSA-001 in Women With Moderate to Severe Diabetic Gastroparesis
In Brief
A Phase 2 clinical trial evaluating CNSA-001 and Placebo for Gastroparesis. Completed, enrolled 21 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartFeb 2019
Primary CompletionSep 2019
Study CompletionOct 2019
TodayJul 2026
First PostedOct 19, 2018
Enrollment StartFeb 27, 2019
Primary CompletionSep 8, 2019
Study CompletionOct 8, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.7 years ago
Interventions
CNSA-001drug
CNSA-001 Powder for Suspension
Placebodrug
Placebo Suspension