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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: E. Sander Connolly
• Collaborators: Food and Drug Administration (FDA); University of Florida; University of Washington
• Treatments: Acetic Acid; Glycine; Retinol acetate

Criteria

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