ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 186 for:    functional | Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03273062
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Lieber Institute for Brain Development
Information provided by (Responsible Party):
Robert Schloesser, MD, Sheppard Pratt Health System

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).


Condition or disease Intervention/treatment Phase
Brain Injuries Brain Injuries, Traumatic Brain Injury, Chronic Drug: Tolcapone 200 MG Other: Placebo Phase 2

Detailed Description:

The proposed study 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).

The outcome measures utilized in this study were chosen based on the available data from the currently ongoing open-label clinical trial. The proposed study will utilize the same study medication at the same dose and frequency. In addition, the length of administration of study medication (two weeks) is identical. In the proposed 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 be evaluated through participant and proxy report. The investigators are planning to randomize a total of 12 patients with BI.

The cross-over design requires two 2-week long study periods during which the participant receives either Tolcapone two 100mg capsules three times a day (total of 600mg/day) or placebo. Participants will be randomly assigned to two sequence groups either starting with Tolcapone treatment (T-P group) or placebo (P-T group). Investigators and participants will be blind to the study group assignment and hence blind to the treatment (Tolcapone vs. placebo) that subjects receive at a given time. The study periods are separated by a "washout period" that is at least two weeks and maximally 4 weeks long to reduce the potential for carryover effects. Patient reported outcomes will be obtained a total of four times, twice prior to the start of each respective study period (Pre-Study Period Visits I & II) as well as at the end of each study period (Outcome Measures Visits I & II). Cognitive outcome measures will be obtained twice throughout the study, at the end of each respective study period (Outcome Measures Visits I & II).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Interventional clinical trial with a double-blind, randomized placebo-controlled crossover design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The participant, respective care provider, as well as the investigator and research coordinator ("outcomes assessor") will all be blind to the order of placebo or medication (Tolcapone) administration in this two-arm, crossover study.
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effects of Catechol-O-Methyltransferase (COMT) Inhibition on Cognition and Neuropsychiatric Symptoms in Patients With a History of Acquired Brain Injuries
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tolcapone

Arm Intervention/treatment
Active Comparator: Study Period 1

15 days of Tolcapone 200mg TID

OR

Placebo Comparator 15 days of Placebo pill TID

Drug: Tolcapone 200 MG
Tolcapone 200 MG TID
Other Name: Tasmar

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

Placebo Comparator: Study Period 2

15 days of Placebo pill TID

OR

Active Comparator 15 days of Tolcapone 200mg TID

Drug: Tolcapone 200 MG
Tolcapone 200 MG TID
Other Name: Tasmar

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




Primary Outcome Measures :
  1. NIH Toolbox Fluid Cognitive Battery [ Time Frame: Administered on the 14th day of Tolcapone or Placebo treatment (i.e. during each Outcome Measures Visit). ]
    This battery is a measure of cognitive performance derived from a battery of five cognitive assessments.


Secondary Outcome Measures :
  1. TBI Quality-of-Life Measurement System [ Time Frame: Administered prior to the start of Tolcapone oe Placebo treatment (i.e. during each Pre-Study Visit) and on the 14th day of Tolcapone or Placebo treatment (i.e. during each Outcome Measures Visit). ]
    A patient reported outcome measure assessing physical, emotional, cognitive and social functioning. Quality of Life Measure is a computer adaptive questionnaire.

  2. Frontal Systems Behavior Scale [ Time Frame: Administered prior to the start of Tolcapone oe Placebo treatment (i.e. during each Pre-Study Visit) and on the 14th day of Tolcapone or Placebo treatment (i.e. during each Outcome Measures Visit). ]
    A patient reported outcome measure, and proxy reported outcome measure, assessing neuropsychiatric symptoms associated with prefrontal cortical dysfunction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273062


Contacts
Contact: Robert J Schloesser, MD 410-938-4610 rschloesser@sheppardpratt.org
Contact: Emily A Berich, BS 410-938-4610 eberich@sheppardpratt.org

Locations
United States, Maryland
Sheppard Pratt Health System Recruiting
Towson, Maryland, United States, 21204
Contact: Robert J Schloesser, MD    410-938-4666    rscloesser@sheppardpratt.org   
Sponsors and Collaborators
Sheppard Pratt Health System
Lieber Institute for Brain Development
Investigators
Principal Investigator: Robert J Schloesser, MD Sheppard Pratt Health System

Responsible Party: Robert Schloesser, MD, Executive Director, Sheppard Pratt-Lieber Research Institute, Inc., Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT03273062     History of Changes
Other Study ID Numbers: 1087860-3
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Robert Schloesser, MD, Sheppard Pratt Health System:
Brain Injury
Traumatic Brain Injury
Acquired Brain Injury
Cognition
Neuropsychiatric Symptopms
COMT

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Injury, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Tolcapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action