Recruiting
Phase 2

COMT Inhibition

Sponsor:

Sheppard Pratt Health System

Code:

NCT03273062

Conditions

Brain Injuries

Brain Injuries, Traumatic

Brain Injury, Chronic

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Tolcapone 200 MG

Placebo

Study Details

Brief 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

Study ID

NCT03273062

Start date

Jul 20, 2017

Status verified date

Sep, 2017

Completion date

Jul 20, 2018

Anticipated

Primary completion date

Jul 20, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Capacity for written informed consent
  • Ages 18-70 years, inclusive
  • Diagnosis of a BI including mild, moderate, or severe TBI, or other acquired BI and post-BI development of neuropsychiatric complaints.
  • Index event resulting in Traumatic or Acquired Brain Injury occurred >12 months prior to trial initiation
  • A current or former patient at the clinics of the Sheppard Pratt Neuropsychiatry Program or another Sheppard Pratt outpatient clinic with medical documentation of BI
  • Proficient in the English language
  • Available to come to Sheppard Pratt Towson for the baseline evaluation and testing and for the duration of the protocol
  • Stable neurological and psychiatric symptomatology for two months prior to trial initiation as determined by the referring Sheppard Pratt physician.
  • Stable medication dose and regimen for two months prior to trial initiation (based on a review of medical chart)

Exclusion Criteria:

  • History of, or active, liver disease or abnormal liver function tests-if the patient currently has elevated Alanine Transaminase (ALT) or Aspartate Transaminase (AST) levels that exceed 2 times the upper limit of normal \[Normal Reference Ranges ALT (Male: 4-40 IU/L, Female: 4-40 IU/L), AST (Male: 4-31 IU/L, Female: 4-37 IU/L) or the ratio of AST: ALT has exceeded 2:1
  • Uncontrolled hypo-or hypertension based on Joint National Committee criteria (JNC7) Hypotension: Systolic <90mmHg or diastolic <60mmHg Hypertension: Systolic >140mmHg or diastolic >90 mmHg)
  • Active alcohol use disorder, as defined by DSM-5, of any severity mild, moderate, or severe
  • Active illicit substance use, resulting in a substance use disorder as defined by DSM-5, of any severity mild, moderate, or severe
  • Patient is currently taking Tolcapone or any of the following medications that can interact with Tolcapone resulting in an adverse event: another COMT inhibitor, benserazide, α-methyldopa, Dobutamine, Apomorphine, Isoproterenol, Clozapine, MAO inhibitor
  • Known allergy or serious adverse reaction to Tolcapone
  • Participated in any investigational drug trial within the past 30 days.
  • Pregnant or planning to become pregnant during the study period
  • Breastfeeding or planning to breastfeed during the study period.
  • Presence of severe pre-morbid/pre-BI cognitive impairment or behavioral dysfunction, as per informant or medical documentation

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Study Period 1

15 days of Tolcapone 200mg TID

OR

Placebo Comparator 15 days of Placebo pill TID

placebo comparator: Study Period 2

15 days of Placebo pill TID

OR

Active Comparator 15 days of Tolcapone 200mg TID

Interventions

Tolcapone 200 MG

Tolcapone 200 MG TID

Placebo

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

Primary outcome measure

  • NIH Toolbox Fluid Cognitive Battery [ Time Frame: Administered on the 14th day of Tolcapone or Placebo treatment (i.e. during each Outcome Measures Visit). ]

Central Contacts and Locations

Central contacts

Robert J Schloesser, MD

410-938-4610rschloesser@sheppardpratt.org

Emily A Berich, BS

410-938-4610eberich@sheppardpratt.org

Locations

Sheppard Pratt Health System

Recruiting

Towson, Maryland, United States, 21204

Contacts

Robert J Schloesser, MD

410-938-4666rscloesser@sheppardpratt.org

More Information

Sponsor

Sheppard Pratt Health System

Last update posted

Sep 6, 2017

Last verified

Sep, 2017

Keywords

  • Brain Injury
  • Traumatic Brain Injury
  • Acquired Brain Injury
  • Cognition
  • Neuropsychiatric Symptopms
  • COMT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sheppard Pratt Health System on 2017-09-06.