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NCT01095731
Phase II Study of the Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage
Phase 2 trial testing Tiopronin in Aneurysmal Subarachnoid Hemorrhage in 60 participants. Completed in 1 July 2013.
1 July 2012
Quick facts
| Lead sponsor | E. Sander Connolly |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 April 2010 |
| Primary completion | 1 July 2012 |
| Estimated completion | 1 July 2013 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Tiopronin — full drug profile →
- Placebo
Conditions studied
- Aneurysmal Subarachnoid Hemorrhage — all drugs for Aneurysmal Subarachnoid Hemorrhage →
Sponsor
E. Sander Connolly
Who can join
21 and older, any sex, with Aneurysmal Subarachnoid Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels
Time frame: Day 7
The level of 3-aminopropanal (3-AP) in cerebrospinal fluid (CSF) measured in nmol/mL. CSF samples taken as a standard of care.
Sponsor's own description
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical trials in cardiac arrest and subarachnoid hemorrhage: lessons from the past and ideas for the future.
Frontera JA. · · 2013 · cited 4× · PMID 23533956 · DOI 10.1155/2013/263974 -
A phase II randomized controlled trial of tiopronin for aneurysmal subarachnoid hemorrhage.
Ironside N, Christophe B, Bruce S, Carpenter AM, et al · · 2020 · cited 1× · PMID 31299655 · DOI 10.3171/2019.4.jns19478
Verify or expand the search:
- PubMed search for NCT01095731
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tiopronin
Trials testing the same drug.
- NCT03663855 — Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria · Phase 2 · completed
Other recruiting trials for Aneurysmal Subarachnoid Hemorrhage
Currently open trials in the same condition.
- NCT06863480 — Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events · Phase 1 · recruiting
- NCT06409364 — FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage · Phase 2 · recruiting
- NCT06494436 — Microvention AnEurysm & STroke Real-life Data cOllection · recruiting
- NCT06548477 — Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages · NA · recruiting
- NCT06288659 — aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01095731 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by E. Sander Connolly
- Last refreshed: 30 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01095731.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing