Brain InjuriesPhase 2NCT03273062
A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury
A Phase 2 study testing Tolcapone 200 MG in people with Brain Injuries and Brain Injuries, Traumatic, run by Sheppard Pratt Health System at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Brain Injuries, Traumatic, Brain Injury, Chronic
- What is being tested?
- Tolcapone 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 20 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sheppard Pratt Health System
Towson, Maryland, 21204
Robert J Schloesser, MD, 410-938-4666, rscloesser@sheppardpratt.org
About this study
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
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).
Read the 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).
- Being tested
- Tolcapone 200 MG, Placebo
- Keywords
- Brain Injury, Traumatic Brain Injury, Acquired Brain Injury, Cognition, Neuropsychiatric Symptopms, COMT
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Brain Injury, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolcapone 200 MGDrug
Also called Tasmar
Tolcapone 200 MG TID
PlaceboOther
Placebo, TID Placebo will be in capsules that are identical in appearance to intervention drug, Tolcapone.
| Study group | Role | What they receive |
|---|---|---|
| Study Period 1 | Active comparator | 15 days of Tolcapone 200mg TID
OR
Placebo Comparator 15 days of Placebo pill TID Receives: Drug: Tolcapone 200 MG; Other: Placebo |
| Study Period 2 | Placebo comparator | 15 days of Placebo pill TID
OR
Active Comparator 15 days of Tolcapone 200mg TID Receives: Drug: Tolcapone 200 MG; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox Fluid Cognitive Battery
This battery is a measure of cognitive performance derived from a battery of five cognitive assessments.
Measured: Administered on the 14th day of Tolcapone or Placebo treatment (i.e. during each Outcome Measures Visit).
Secondary outcomes (2)
TBI Quality-of-Life Measurement System
A patient reported outcome measure assessing physical, emotional, cognitive and social functioning. Quality of Life Measure is a computer adaptive questionnaire.
Measured: 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).
Frontal Systems Behavior Scale
A patient reported outcome measure, and proxy reported outcome measure, assessing neuropsychiatric symptoms associated with prefrontal cortical dysfunction
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start20 Jul 2017
- Primary completion20 Jul 2018 (estimated)
- Study completion20 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional clinical trial with a double-blind, randomized placebo-controlled crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheppard Pratt Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Lieber Institute for Brain Development
- Responsible party
- Principal investigator, Robert Schloesser, MD, Sheppard Pratt Health System
- Investigators
- Robert J Schloesser, MD, Principal investigator, Sheppard Pratt Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273062
- Sponsor's protocol ID
- 1087860-3
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03273062
- Acronym / sponsor ID
- 1087860-3
- Keywords
- Brain Injury, Traumatic Brain Injury, Acquired Brain Injury, Cognition, Neuropsychiatric Symptopms, COMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Sheppard Pratt Health SystemUniversity, hospital or other
- Collaborators
- Lieber Institute for Brain Development
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Jul 2018 (estimated)
- Study completion
- 20 Jul 2018 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional clinical trial with a double-blind, randomized placebo-controlled crossover design
| Arm | Type | Receives |
|---|---|---|
| Study Period 1 | Active comparator | Drug: Tolcapone 200 MG, Other: Placebo15 days of Tolcapone 200mg TID OR Placebo Comparator 15 days of Placebo pill TID |
| Study Period 2 | Placebo comparator | Drug: Tolcapone 200 MG, Other: Placebo15 days of Placebo pill TID OR Active Comparator 15 days of Tolcapone 200mg TID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolcapone 200 MGAlso: TasmarTolcapone 200 MG TID | Drug | Study Period 1, Study Period 2 |
| PlaceboPlacebo, TID Placebo will be in capsules that are identical in appearance to intervention drug, Tolcapone. | Other | Study Period 1, Study Period 2 |
Primary outcome
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.
2 secondary outcomes
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Schloesser, MD principal investigator
Sheppard Pratt Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolcapone 200 MG in people with Brain Injuries and Brain Injuries, Traumatic, run by Sheppard Pratt Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert J Schloesser, MD (410-938-4610, rschloesser@sheppardpratt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.