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COMT Inhibitor

Study Period 1 for Traumatic 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

Study 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

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

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

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
21 Previous Clinical Trials
7,793 Total Patients Enrolled
Robert J Schloesser, MDPrincipal InvestigatorSheppard Pratt Health System
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury
Robert Schloesser, MD 2017. "A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03273062.
All > Brain Injury
~2 spots leftby Apr 2025
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