CompletedPhase 2

The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage

United States60 participantsStarted 2010-04

Plain-language 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

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Admitted to a recruiting center with aneurysmal subarachnoid hemorrhage * Ability to initiate study drug treatment within 96 hours of aSAH onset. * Ability to provide either informed or surrogate consent Exclusion Criteria: * Hypersensitivity to penicillamine * Creatinine level greater than 1.5/mm\^3 on admission * Platelet count of less than 100,000/mm\^3 on admission * White blood cell count of less than 3.5/mm\^3 on admission * AST or ALT of greater than 60/L on admission or history of liver failure * Pregnancy * History of lupus, Goodpasture's syndrome, myasthenia gravis, pemphigus, nephrotic syndrome, glomerulonephritis, or renal failure * Patients considered unable to comply with the protocol

What they're measuring

Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels

Timeframe: Day 7

Trial details

NCT IDNCT01095731

SponsorE. Sander Connolly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

Results submitted2025-09-30

View on ClinicalTrials.gov More Aneurysmal Subarachnoid Hemorrhage trials