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COMT Inhibitor

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

Phase 2
Waitlist Available
Led By Robert J Schloesser, MD
Research Sponsored by Sheppard Pratt Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered on the 14th day of tolcapone or placebo treatment (i.e. during each outcome measures visit).
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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).

Eligible Conditions
  • Traumatic Brain Injury
  • Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered on the 14th day of tolcapone or placebo treatment (i.e. during each outcome measures visit).
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered on the 14th day of tolcapone or placebo treatment (i.e. during each outcome measures visit). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NIH Toolbox Fluid Cognitive Battery
Secondary study objectives
Frontal Systems Behavior Scale
TBI Quality-of-Life Measurement System

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Study Period 1Active Control2 Interventions
15 days of Tolcapone 200mg TID OR Placebo Comparator 15 days of Placebo pill TID
Group II: Study Period 2Placebo Group2 Interventions
15 days of Placebo pill TID OR Active Comparator 15 days of Tolcapone 200mg TID

Find a Location

Who is running the clinical trial?

Lieber Institute for Brain DevelopmentUNKNOWN
Sheppard Pratt Health SystemLead Sponsor
22 Previous Clinical Trials
7,828 Total Patients Enrolled
Robert J Schloesser, MDPrincipal InvestigatorSheppard Pratt Health System
1 Previous Clinical Trials
100 Total Patients Enrolled
~2 spots leftby Dec 2025
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