Trial · NCT01095731

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

NCT01095731, Phase 2, Completed, E. Sander Connolly; results first posted 2025-10-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage. Trials, record NCT01095731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01095731

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage
NCT number: NCT01095731
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: E. Sander Connolly
Conditions: Aneurysmal Subarachnoid Hemorrhage
Interventions: Tiopronin, Placebo
First posted: 2010-03-30
Last updated: 2025-10-29
Results first posted: 2025-10-29

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	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.
Secondary	Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Day 14	The level of 3-aminopropanal (3-AP) in cerebrospinal fluid (CSF) measured in nmol/mL. CSF samples taken as a standard of care.
Secondary	Modified Rankin Score (mRS) at Discharge	At time of discharge, approximately Day 14	The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 (no symptoms) to 5 (severe disability).
Secondary	Modified Rankin Score (mRS) at 3 Months	3 months	The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 (no symptoms) to 5 (severe disability).
Secondary	Modified Rankin Score (mRS) at 12 Months	12 months	The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 (no symptoms) to 5 (severe disability).
Secondary	Barthel Index at Discharge	At time of discharge, approximately Day 14	Barthel index is a scale used to measure dependency in performing daily activities. Scores range from 0 (total dependency) to 100 (no dependency). A higher score indicates a better outcome.
Secondary	Barthel Index at 3 Months	3 months	Barthel index is a scale used to measure dependency in performing daily activities. Scores range from 0 (total dependency) to 100 (no dependency). A higher score indicates a better outcome.
Secondary	Barthel Index at 12 Months	12 months	Barthel index is a scale used to measure dependency in performing daily activities. Scores range from 0 (total dependency) to 100 (no dependency). A higher score indicates a better outcome.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Day 7	CSF samples were successfully collected on day 7 in 12 and 13 participants in the tiopronin and sugar pill arms, respectively.	nmol/mL	MEAN
SECONDARY	Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Day 14	CSF samples were successfully collected on day 14 in 13 and 9 participants in the tiopronin and sugar pill arms respectively.	nmol/mL	MEAN
SECONDARY	Modified Rankin Score (mRS) at Discharge	At time of discharge, approximately Day 14		score on a scale	MEDIAN
SECONDARY	Modified Rankin Score (mRS) at 3 Months	3 months		score on a scale	MEDIAN
SECONDARY	Modified Rankin Score (mRS) at 12 Months	12 months		score on a scale	MEDIAN
SECONDARY	Barthel Index at Discharge	At time of discharge, approximately Day 14		score on a scale	MEAN
SECONDARY	Barthel Index at 3 Months	3 months		score on a scale	MEAN
SECONDARY	Barthel Index at 12 Months	12 months		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Tiopronin, Hunt Hess Grade I-V	11.1	Standard Deviation 11.8	nmol/mL
Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Sugar Pill, Hunt Hess Grade I-V	12.9	Standard Deviation 17.6	nmol/mL
Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Tiopronin, Hunt Hess Grade I-V	14.7	Standard Deviation 18.8	nmol/mL
Cerebrospinal Fluid 3-aminopropanal (CSF-3AP) Levels	Sugar Pill, Hunt Hess Grade I-V	9.9	Standard Deviation 10.3	nmol/mL
Modified Rankin Score (mRS) at Discharge	Tiopronin, Hunt Hess Grade I-V	4	Inter-Quartile Range 2 to 5	score on a scale
Modified Rankin Score (mRS) at Discharge	Sugar Pill, Hunt Hess Grade I-V	4	Inter-Quartile Range 3 to 5	score on a scale
Modified Rankin Score (mRS) at 3 Months	Tiopronin, Hunt Hess Grade I-V	3	Inter-Quartile Range 2 to 4	score on a scale
Modified Rankin Score (mRS) at 3 Months	Sugar Pill, Hunt Hess Grade I-V	2	Inter-Quartile Range 1 to 4	score on a scale
Modified Rankin Score (mRS) at 12 Months	Tiopronin, Hunt Hess Grade I-V	2	Inter-Quartile Range 1 to 2	score on a scale
Modified Rankin Score (mRS) at 12 Months	Sugar Pill, Hunt Hess Grade I-V	2	Inter-Quartile Range 1 to 3	score on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tiopronin, Hunt Hess Grade I-V	30
Overall Study	STARTED	Sugar Pill, Hunt Hess Grade I-V	29
Overall Study	COMPLETED	Tiopronin, Hunt Hess Grade I-V	29
Overall Study	COMPLETED	Sugar Pill, Hunt Hess Grade I-V	27
Overall Study	NOT COMPLETED	Tiopronin, Hunt Hess Grade I-V	1
Overall Study	NOT COMPLETED	Sugar Pill, Hunt Hess Grade I-V	2

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fever	General disorders	Tiopronin, Hunt Hess Grade I-V	5	29
other	Fever	General disorders	Sugar Pill, Hunt Hess Grade I-V	5	27
other	Thrombosis	Vascular disorders	Tiopronin, Hunt Hess Grade I-V	1	29
other	Thrombosis	Vascular disorders	Sugar Pill, Hunt Hess Grade I-V	1	27
other	Seizure	Nervous system disorders	Tiopronin, Hunt Hess Grade I-V	2	29
other	Seizure	Nervous system disorders	Sugar Pill, Hunt Hess Grade I-V	1	27
other	Thrombocytopenia	Blood and lymphatic system disorders	Tiopronin, Hunt Hess Grade I-V	1	29
other	Thrombocytopenia	Blood and lymphatic system disorders	Sugar Pill, Hunt Hess Grade I-V	1	27
other	Hypernatremia	General disorders	Tiopronin, Hunt Hess Grade I-V	2	29
other	Hypernatremia	General disorders	Sugar Pill, Hunt Hess Grade I-V	1	27

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tiopronin, Hunt Hess Grade I-V	4	29
Total, all-cause mortality	Sugar Pill, Hunt Hess Grade I-V	3	27
Total, other adverse events	Tiopronin, Hunt Hess Grade I-V	13	29
Total, other adverse events	Sugar Pill, Hunt Hess Grade I-V	16	27
Total, serious adverse events	Tiopronin, Hunt Hess Grade I-V	6	29
Total, serious adverse events	Sugar Pill, Hunt Hess Grade I-V	9	27

Source ClinicalTrials.gov

Papers16

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1499692	BACKGROUND	PubMed
3895589	BACKGROUND	PubMed
7354892	BACKGROUND	PubMed
7676533	BACKGROUND	PubMed
7774210	BACKGROUND	PubMed
8584670	BACKGROUND	PubMed
8614919	BACKGROUND	PubMed
8711808	BACKGROUND	PubMed
9056628	BACKGROUND	PubMed
9670045	BACKGROUND	PubMed

1 to 10 of 16

See all 16 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01FD003728	Phase II Trial of Tiopronin in Aneurysmal Subarachnoid Hemorrhage	CONNOLLY, EDWARD SANDER	COLUMBIA UNIVERSITY HEALTH SCIENCES	FOOD AND DRUG ADMINISTRATION	2009 to 2011

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tiopronin, Hunt Hess Grade I-V vs Sugar Pill, Hunt Hess Grade I-V: deaths from any cause	Trial comparisons
Tiopronin, Hunt Hess Grade I-V vs Sugar Pill, Hunt Hess Grade I-V: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01095731

GET https://conductscience.org/api/trials/v1/NCT01095731/events?page=2

API reference For AI assistants