CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Tiopronin +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.

Search/NCT01095731
NCT01095731Phase 2Completed
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Phase II Study of the Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage

E. Sander Connolly·interventional·Posted Mar 30, 2010·Updated Oct 29, 2025

In Brief

A Phase 2 clinical trial evaluating Tiopronin and Placebo for Aneurysmal Subarachnoid Hemorrhage. Completed, enrolled 60 participants across 3 sites.

Detailed Summary

The purpose of this phase II study is to further assess the safety of tiopronin in aneurysmal subarachnoid hemorrhage(aSAH) patients in order to obtain preliminary data on the efficacy of tiopronin versus placebo in reducing serum and cerebrospinal fluid (CSF) 3AP levels in this patient population. Funding Source - FDA Office of Orphan Products Development

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAneurysmal Subarachnoid Hemorrhage
CountriesUnited States
CollaboratorsUniversity of Florida, University of Washington, Food and Drug Administration (FDA)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2010
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.3 years ago

Interventions

Tiopronindrug

Dosage will be 1 gram, 3 times daily. Drug dosing will be initiated at time of aSAH confirmation, for a length of 14 days or at hospital discharge.

Placebodrug

Dosage will be 1 gram, 3 times daily. Drug dosing will be initiated at time of aSAH confirmation, for a length of 14 days or at hospital discharge.