Advertisement

Topics

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

2014-08-27 03:14:53 | BioPortfolio

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 CSF 3AP levels in this patient population.

Description

The annual rate of aSAH in United States is approximately 18 to 24 thousand cases each year. Mortality rates following aSAH range from 30-70% with 10-20% of survivors experiencing severe neurological disability. Following aSAH, a major cause of morbidity and mortality is vasospasm, which causes delayed ischemic neurologic deterioration. There is currently no effective treatment for preventing or ameliorating the damage that occurs following cerebral ischemia. A myriad of neuro-toxins are produced in the ischemic brain resulting in a vicious cycle of cellular death and destruction. The polyamines spermine and spermidine are metabolized by polyamine oxidase (PAO) into putrescine and 3-aminopropanal (3AP).

Tiopronin (Thiola) is an FDA approved drug used for the treatment of cystine stones in patients with cystinuria in the U.S. In Europe, it is also used for the treatment of rheumatoid arthritis and bronchial hypersecretion. In previous animal studies, we demonstrated that tiopronin is able to bind and neutralize the toxic effects of 3AP. We have shown in previous studies that aSAH patients have elevated 3AP levels, and higher levels correlate to a poor neurologic outcome.

The goals of this phase II multicenter, randomized, double-blinded safety and efficacy trial are to (1) further evaluate the safety of the drug in our patient population at the dose established in phase I; (2) demonstrate that tiopronin crosses the BBB; (3) show that both serum and CSF 3AP levels are reduced by administration of tiopronin; and (4) demonstrate that a reduction in 3AP levels is associated with improved neurologic outcome in aSAH patients.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Aneurysmal Subarachnoid Hemorrhage

Intervention

Tiopronin for Hunt Hess grades I-III, Placebo for Hunt Hess grades I-III, Placebo for Hunt Hess grades IV-V, Tiopronin for Hunt Hess grades IV-V

Location

University of Florida
Gainesville
Florida
United States
32611

Status

Recruiting

Source

Columbia University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:53-0400

Clinical Trials [103 Associated Clinical Trials listed on BioPortfolio]

Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance

In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight manageme...

Use of Classic LMA During Endovascular Therapy

Background: Earlier treatment and resolution for patients with cerebral aneurysms is now possible due to earlier diagnosis. This observational study aims to evaluate the intraoperative car...

Associations of the Grades of Doctor and Neonatal Outcomes

In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.

Hypopituitarism After Aneurismal Subarachnoid Hemorrhage

Introduction: Almost 50% of patients die after aneurismal subarachnoid hemorrhage (aSAH). 30% of the survivors suffer from neurological handicap and need permanent care (Suarez et al.). E...

Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation

Twenty-four (2 x 12) patients with intestinal graft versus host disease (GVHD) Grades 2, 3 or 4 will be treated with budesonide 3mg three times daily or placebo for 12 weeks. All of the p...

PubMed Articles [1170 Associated PubMed Articles listed on BioPortfolio]

Comparison of postsurgical clinical sequences between completely embolized and incompletely embolized patients with wide nicked intracranial aneurysms treated with stent assisted coil embolization technique: A STROBE-compliant study.

The technique of stent-assisted coil embolization has been widely used in the clinic, while its efficacy and safety have yet to be evaluated. This study investigates the values of computed tomography ...

Hunt-Hess 5 Subarachnoid Haemorrhage Presenting with Cardiac Arrest is Associated with Larger Volume Bleeds.

The mechanism, effects, and outcomes of cardiac arrest (CA) caused by subarachnoid haemorrhage (SAH) remain unclear. We compared SAH patients presenting with CA to other high-grade SAH patients presen...

Comparison of Stent-Assisted Coil Placement and Coiling-Only for the Treatment of Ruptured Intracranial Aneurysms.

BACKGROUND The use of a stent during the acute post-hemorrhage period is controversial. We conducted a retrospective analysis on the clinical and angiographic outcomes of the ruptured aneurysms that w...

Comparison of a new digital KM screen test with conventional Hess and Lees screen tests in the mapping of ocular deviations.

To evaluate the digital KM screen computerized ocular motility test and to compare it with conventional nondigital techniques using the Hess and Lees screens.

Relationship between external ventricular drain clamp trials and ventriculoperitoneal shunt insertion following nontraumatic subarachnoid hemorrhage: a single-center study.

OBJECTIVE Currently, there is no established standard regarding the ideal number of external ventricular drain (EVD) clamp trials performed before ventriculoperitoneal (VP) shunt insertion following n...

Medical and Biotech [MESH] Definitions

A distinct and virulent form of DENGUE characterized by thrombocytopenia and hemoconcentration (grades I and II) and distinguished by a positive tourniquet test. When accompanied by circulatory failure and shock (grades III and IV), it is called dengue shock syndrome. (From Dorland, 28th ed)

A virulent form of dengue characterized by THROMBOCYTOPENIA and an increase in vascular permeability (grades I and II) and distinguished by a positive pain test (e.g., TOURNIQUET PAIN TEST). When accompanied by SHOCK (grades III and IV), it is called dengue shock syndrome.

Any of several large carnivorous mammals of the family CANIDAE that usually hunt in packs.

The family Hirundinidae, comprised of small BIRDS that hunt flying INSECTS while in sustained flight.

An order of BIRDS with the common name owls characterized by strongly hooked beaks, sharp talons, large heads, forward facing eyes, and facial disks. While considered nocturnal RAPTORS, some owls do hunt by day.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...


Searches Linking to this Trial