Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT01577966
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
A Pilot Study to Determine the Effect of Sulfasalazine on Glutamate Levels Detected by Magnetic Resonance Spectroscopy(MRS) in Patients With Glioma
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this part of the study is to determine the Central Nervous System bioavailability of sulfasalazine.
Detailed Description:
This is a pilot, open-label, non-randomized, study to determine the effect that orally administered sulfasalazine has on glutamate levels as measured by MRS and on epileptiform spiking as measured by simultaneous MEG/EEG. The intent of the dose escalation is to determine an Optimal Biological Dose (OBD) based on changes in tumor glutamate levels. The OBD is defined as the dose that has the maximal reduction in tumor glutamate levels after normalization to uninvolved brain.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: