Overcoming Membrane Transporters to Improve CNS Drug Delivery - Improving Brain Antioxidants After Traumatic Brain Injury

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pediatric Traumatic Brain Injury

In brief

The overall purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury. Traumatic brain injuries are the leading cause of death and disability among children and young adults. Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after TBI and can overcome barriers to the brain and synergistically improve bioavailability and efficacy the antioxidant content of the body and CNS after TBI.

Key facts

Study ID

NCT01322009

Run by

University of Pittsburgh

People needed

14

Starts

2011-03-01

Expected to finish

2015-03-01

Last updated by the study team

2016-08-15

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children (age 2 - 18 y) with severe TBI (GCS < or = 8) with an externalized ventricular drain placed for measurement of intracranial pressure

You may not qualify if…

• Brain dead on admission to ICU
• Pregnancy
• Contraindications to enteral medications
• Contraindications to probenecid:
• status epilepticus
• blood dyscrasias
• under 2 years-of-age
• coadministration of salicylates
• renal dysfunction or urate kidney stones
• hypersensitivity to probenecid
• Contraindications to N-acetylcysteine: hypersensitivity to N-acetylcysteine
• Family unwilling to consent

Where it is running

• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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