Brain Injuries, TraumaticPhase 2NCT02652598
Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD
A Phase 2 study testing Tolcapone in people with Brain Injuries, Traumatic and Neurocognitive Disorders, run by Sheppard Pratt Health System at 1 site in United States.
Trial summary
The experimental design is an open-label two-week trial of tolcapone to evaluate which clinical domains are affected by tolcapone treatment and to identify "responders" to tolcapone treatment in the two subject groups (BI and NCD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injuries, Traumatic, Neurocognitive Disorders, Brain Injuries
- What is being tested?
- Tolcapone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
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
- Active alcohol use disorder, as defined by DSM-5, of any severity mild, moderate, or severe
- History of, or active, cardiovascular disease defined as: coronary heart disease, manifested by myocardial infarction, angina pectoris, or heart failure
- Uncontrolled hypo-or hypertension based on Joint National Committee criteria (JNC7) Hypotension: Systolic<90mmHg or diastolic<60mmHg Hypertension: Systolic >140mmHg or diastolic>90 mmHg)
- History of extra-pyramidal symptoms (e.g. tardive dyskinesia, neuroleptic malignant syndrome, or QT prolongation) while on a first-generation anti-psychotic
- Active illicit substance use, resulting in a substance use disorder as defined by DSM-5, of any severity mild, moderate, or severe
Show all 13Show fewer
- Patient is currently taking tolcapone or any of the following medications that can interact with tolcapone resulting in an adverse events: 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 in the past 30 days.
- Pregnant or planning to become pregnant during the study period
- Breastfeeding or planning to breastfeed during the study period.
- Other Exclusion Criteria for TBI Patients
- Presence of pre-morbid/pre-TBI cognitive impairment or behavioral dysfunction, as per informant or medical documentation
Trial locations and contacts
1 site in 1 country.
United States1 site
Sheppard Pratt Health System
Baltimore, Maryland, 21204
About this study
Official title: A Proof of Concept Open-label Study to Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With Traumatic Brain Injury (TBI), Other Acquired Brain Injuries (ABI), or a Diagnosis of Neurocognitive Disorder (NCD)
The experimental design is an open-label two-week trial of tolcapone to evaluate which clinical domains are affected by tolcapone treatment and to identify "responders" to tolcapone treatment in the two subject groups (BI and NCD)
Read the detailed description
Each patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions.
Clinical Instruments for patients:
- Question banks from large patient-reported outcome measure initiatives will be used and administered and used by computerized-adaptive tests (CATs). These include the TBI-QoL for patients with TBI and question banks from the patient-reported outcome measure information systems (PROMIS) and neurology quality of life measurement initiative (Neuro-QoL). Patients will answer questions related to their mobility, fatigue, pain interference, positive affect and well-being, depression, anxiety, anger and irritability, and emotional and behavioral dyscontrol.
- Clinical Global Impressions Scale
- Geriatric Depression Scale-15
- State-Trait Anxiety Inventory
- Hopkins Adult Reading Test
- Frontal Systems Behavior Scale
- Montreal Cognitive Assessment
- Trails A\&B
- Modified Wisconsin Card Sorting Test
- NIH Toolbox
- Perceptual Comparison Test
- Brief Test of Attention
- Hopkins Verbal Learning Test
- Brief Visuospatial Memory Test
- Calibrated Ideational Fluency Assessment
- Profile of Mood States
- Digit Span
Clinical Instruments for Informants:
- Neuropsychiatry Inventory
- Apathy evaluation scale
- Overt aggression scale
- Frontal Systems Behavior Scale
Laboratory Measures:
- Blood sample for genotyping
- Blood sample for assessing COMT activity.
- Blood sample for a laboratory profile including CBC, CMP, TSH, Hepatitis Panel (B and C), and RPR
- A urine analysis, urine drug screen, and a urine pregnancy test
- In addition for NCD patients: a blood sample for tests including Serum Calcium, B12, ESR, and C-reactive protein
- Being tested
- Tolcapone
- Medical subject headings
- Brain Injuries, Traumatic, Neurocognitive Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Also called Tasmar
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Experimental | Each patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions. Receives: Drug: Tolcapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Clinical Global Impression Scale (CGI) to two weeks after medication administration
Measured: Up to 2 weeks
Secondary outcomes (2)
Change from Baseline TBI-QoL to two weeks after medication administration
Questions from the TBI-QoL battery, which consists of tests to assess items on domains of emotion, social activity, physical activity, and cognition
Measured: Up to 2 weeks
Change from Baseline NIH Toolbox Cognition Battery to two weeks after medication administration
A cognition battery developed by NIH, which consists of tests to assess Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheppard Pratt Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Lieber Institute for Brain Development (LIBD)
- 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
- NCT02652598
- Sponsor's protocol ID
- 805704
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Open-label Study to Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With Traumatic Brain Injury (TBI), Other Acquired Brain Injuries (ABI), or a Diagnosis of Neurocognitive Disorder (NCD)
- ClinicalTrials.gov ID
- NCT02652598
- Acronym / sponsor ID
- 805704
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheppard Pratt Health SystemUniversity, hospital or other
- Collaborators
- Lieber Institute for Brain Development (LIBD)
- Study start
- Nov 2015
- Primary completion
- Jan 2020 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- 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.
The experimental design is an open-label two-week trial of tolcapone to evaluate which clinical domains are affected by tolcapone treatment and to identify "responders" to tolcapone treatment in the two subject groups (BI and NCD)
Detailed description
Each patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions.
Clinical Instruments for patients:
- Question banks from large patient-reported outcome measure initiatives will be used and administered and used by computerized-adaptive tests (CATs). These include the TBI-QoL for patients with TBI and question banks from the patient-reported outcome measure information systems (PROMIS) and neurology quality of life measurement initiative (Neuro-QoL). Patients will answer questions related to their mobility, fatigue, pain interference, positive affect and well-being, depression, anxiety, anger and irritability, and emotional and behavioral dyscontrol.
- Clinical Global Impressions Scale
- Geriatric Depression Scale-15
- State-Trait Anxiety Inventory
- Hopkins Adult Reading Test
- Frontal Systems Behavior Scale
- Montreal Cognitive Assessment
- Trails A\&B
- Modified Wisconsin Card Sorting Test
- NIH Toolbox
- Perceptual Comparison Test
- Brief Test of Attention
- Hopkins Verbal Learning Test
- Brief Visuospatial Memory Test
- Calibrated Ideational Fluency Assessment
- Profile of Mood States
- Digit Span
Clinical Instruments for Informants:
- Neuropsychiatry Inventory
- Apathy evaluation scale
- Overt aggression scale
- Frontal Systems Behavior Scale
Laboratory Measures:
- Blood sample for genotyping
- Blood sample for assessing COMT activity.
- Blood sample for a laboratory profile including CBC, CMP, TSH, Hepatitis Panel (B and C), and RPR
- A urine analysis, urine drug screen, and a urine pregnancy test
- In addition for NCD patients: a blood sample for tests including Serum Calcium, B12, ESR, and C-reactive protein
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Experimental | Drug: TolcaponeEach patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 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
- Active alcohol use disorder, as defined by DSM-5, of any severity mild, moderate, or severe
- History of, or active, cardiovascular disease defined as: coronary heart disease, manifested by myocardial infarction, angina pectoris, or heart failure
- Uncontrolled hypo-or hypertension based on Joint National Committee criteria (JNC7) Hypotension: Systolic<90mmHg or diastolic<60mmHg Hypertension: Systolic >140mmHg or diastolic>90 mmHg)
- History of extra-pyramidal symptoms (e.g. tardive dyskinesia, neuroleptic malignant syndrome, or QT prolongation) while on a first-generation anti-psychotic
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 |
|---|---|---|
| TolcaponeAlso: Tasmar | Drug | Open-Label |
Primary outcome
Change from Baseline Clinical Global Impression Scale (CGI) to two weeks after medication administration
Time frame: Up to 2 weeks
2 secondary outcomes
Change from Baseline TBI-QoL to two weeks after medication administration
Time frame: Up to 2 weeks
Change from Baseline NIH Toolbox Cognition Battery to two weeks after medication administration
Time frame: Up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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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 in people with Brain Injuries, Traumatic and Neurocognitive Disorders, 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 0 inclusion and 13 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 19 Jan 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Clinical Global Impression Scale (CGI) to two weeks after medication administration (time frame: Up to 2 weeks). 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 19 Jan 2017.