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

NCT03273062 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-09-06

No results posted yet for this 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).

Conditions

  • Brain Injuries
  • Brain Injuries, Traumatic
  • Brain Injury, Chronic

Interventions

DRUG

Tolcapone 200 MG

Tolcapone 200 MG TID

OTHER

Placebo

Placebo, TID Placebo will be in capsules that are identical in appearance to intervention drug, Tolcapone.

Sponsors & Collaborators

  • Lieber Institute for Brain Development

    collaborator UNKNOWN

  • Sheppard Pratt Health System

    lead OTHER

Principal Investigators

  • Robert J Schloesser, MD · Sheppard Pratt Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2018-07-20
Completion
2018-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273062 on ClinicalTrials.gov