Phase 2
Completed N=59
The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage
Source: ClinicalTrials.gov NCT01095731 ↗Enrolled (actual)
59
Serious AEs
26.8%
Results posted
Oct 2025
Primary outcomePrimary: Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels — 11.1; 12.9 nmol/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels |
14.7; 9.9 | — |
| SECONDARY Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels |
14.7; 9.9 | — |
| SECONDARY Modified Rankin Score (mRS) at Discharge |
4; 4 | — |
| SECONDARY Modified Rankin Score (mRS) at 3 Months |
3; 2 | — |
| SECONDARY Modified Rankin Score (mRS) at 12 Months |
2; 2 | — |
| SECONDARY Barthel Index at Discharge |
37; 30 | — |
| SECONDARY Barthel Index at 3 Months |
83; 85 | — |
| SECONDARY Barthel Index at 12 Months |
94; 98 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01095731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.