drugset / Trial / NCT03273062

A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury

NCT03273062

RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a follow-up study for an ongoing open label trial conducted by the Sheppard Pratt-Lieber Research Institute utilizing the catechol-O-methyl-transferase (COMT) inhibitor Tolcapone to evaluate its effects on cognition and neuropsychiatric symptoms in patients with brain injuries (BI). In this study, investigators will conduct a double-blind, placebo-controlled clinical trial utilizing a crossover design to study the effects of two weeks of Tolcapone 200mg administered three times a day (total of 600mg/day) on cognitive performance. Physical, emotional, cognitive and social functioning will also be evaluated through participant and proxy report. The investigators are planning to randomize a total of 12 patients with a history of acquired brain injury (BI).

Timeline

Start
2017-07-20
Primary completion
2018-07-20
Completion
2018-07-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tolcapone Unknown 200 mg