CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 55 enrolled
Drug / intervention
Tolcapone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02260570
NCT02260570Early Ph 1Completed

Remediation of Impaired Self-Regulation in Patients With Mild TBI

VA Office of Research and Development·interventional·Posted Oct 9, 2014·Updated Sep 22, 2025

In Brief

A Early Phase 1 clinical trial evaluating Tolcapone and Placebo for Mild Traumatic Brain Injury. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions. This self regulation can be compromised in individuals who have a history of mild traumatic brain injury and co-occurring disorders. In this study the investigators are using functional MRI scanning to understand how memory and self regulation are expressed in the brains of people with a history of mild traumatic brain injury. The investigators are also testing whether the medication tolcapone may improve memory and self regulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartAug 1, 2015
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.7 years ago

Interventions

Tolcaponedrug

COMT Inhibitor

Placebodrug

A pill that contains no active ingredient