Status:
UNKNOWN
A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury
Lead Sponsor:
Sheppard Pratt Health System
Collaborating Sponsors:
Lieber Institute for Brain Development
Conditions:
Brain Injuries
Brain Injuries, Traumatic
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03273062
Start Date
July 20 2017
End Date
July 20 2018
Last Update
September 6 2017
Active Locations (1)
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1
Sheppard Pratt Health System
Towson, Maryland, United States, 21204