Phase 2 N=14 Randomized Quadruple-blind Treatment

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

Pediatric Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT01322009 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Aug 2016

Primary outcome: Primary: Number of Participants Who Experienced Adverse Events — 0; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Probenecid and N-acetyl cysteine (Drug); Placebo (Drug)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced Adverse Events	0; 2	—
SECONDARY Antioxidant Reserve	751; 735	>0.05

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01322009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.