Mild to Moderate TBIPhase 1/2NCT04262895
TTI-0102 for Veterans With TBI
A Phase 1/2 study testing TTI-0102 in people with Mild to Moderate TBI and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Traumatic brain injury (TBI) is a signature wound of the recent wars. How chronic TBI symptoms develop after a mild brain injury is not fully understood, but it is now thought that injury results in damage that reduces brain energy production, increases inflammation, and results in a leaky blood-brain barrier. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild to Moderate TBI, Posttraumatic Stress Disorder
- What is being tested?
- TTI-0102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 15 Oct 2021
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran receiving care at the VA San Diego Healthcare system
- age 18-65
- history of mild to moderate TBI (loss of consciousness <24 hours; posttraumatic amnesia <7 days)
- documented impairment (>1 standard deviation below the mean) in at least one neuropsychological domain as determined by valid clinical neuropsychological testing using at least one performance validity test, i.e.:
- attention
- processing speed
Show all 10Show fewer
- working memory
- learning, memory
- executive functioning
- DSM-5 diagnosis of PTSD based on the Clinician-Administered PTSD Scale
Who cannot join
- current alcohol and/or substance abuse or dependence
- high risk for homicide or suicide
- evidence of a significant uncontrolled/unstable medical illness or clinically significant surgery
- laboratory values that are significantly outside normal limits
- history of intolerance or hypersensitivity to cysteamine or penicillamine
- current participation in other intervention studies
- pregnant or intending to become pregnant in the next 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: TTI-0102, a Cysteamine Precursor for Mild to Moderate TBI: Dosing and Feasibility Study
Traumatic brain injury (TBI) is a signature wound of the recent wars. How chronic TBI symptoms develop after a mild brain injury is not fully understood, but it is now thought that injury results in damage that reduces brain energy production, increases inflammation, and results in a leaky blood-brain barrier. Difficulties in daily function may persist in areas such as thinking (e.g., attention, learning, memory, planning, and problem-solving), pain (e.g., headache) and behavior (e.g., sleep, posttraumatic stress disorder, depression). No medications for TBI have been developed, so evidence-based cognitive rehabilitation interventions such as Compensatory Cognitive Training (CCT) are the mainstay of treatment. The investigators are proposing to study a medication, TTI-0102, that shows anti-inflammatory activity, as a potential adjunct treatment with CCT for Veterans with TBI-related symptoms. The investigators plan to first determine the best dose of TTI-0102 to use, and then to conduct a pilot study to test the feasibility and acceptability of combining TTI-0102 with CCT in Veterans with mild to moderate TBI and PTSD.
Read the detailed description
Approximately 12-23% of returning service members report a history of traumatic brain injury, mostly mild (mTBI). Post-concussive symptoms such as memory problems, irritability, and difficulty concentrating are common after TBI and may become chronic, interfering with successful return to duty or civilian reintegration, reducing quality of life, and increasing health care utilization for Veterans. In those whose TBI-related symptoms persist, there is accumulating evidence for increased morbidity (e.g., worse PTSD symptoms, chronic hypopituitarism, dementia), spurring efforts to improve diagnosis and intervention. Following a primary TBI injury, secondary injury and persistent symptoms may evolve through a complex cascade of events that culminate in inflammation, alterations in mitochondrial bioenergetics, and diminished blood brain barrier integrity, ultimately yielding a chronic disease state. To date, Veterans receiving strategy-based cognitive rehabilitation for TBI (CCT/CogSMART) have shown improvement in cognition and subjective neuropsychiatric symptoms. CCT is an evidence-based cognitive rehabilitation intervention emphasizing training in cognitive strategies to improve post-concussive symptoms, attention, learning/memory, and executive functioning. However, no pharmaceuticals have been developed for direct or adjunct-to CCT use to maximize treatment outcomes.
Given that inflammation has been observed in TBI, PTSD, and in co-occurring TBI/PTSD, it may be an important aspect of the TBI/PTSD disease state that could be manipulated to promote healing. The investigators are proposing to study TTI-0102, a cysteamine precursor that shows anti-inflammatory activity, as a potential adjunct to CCT for Veterans with TBI-related symptoms. TTI-0102 is a safe, easily administered, highly-water soluble compound that readily crosses the blood brain barrier. Compared with cysteamine, TTI-0102 degrades more slowly, dampening peak drug concentrations and sustaining drug plasma concentrations in a narrow therapeutic range. Developed to treat cystinosis, cysteamine is now believed to have potential for treatment of neurodegenerative disorders.
The goal of this proof of concept study is first, in Phase I (Year 1), to use symptom change (i.e., objective cognitive performance and subjective cognitive and neuropsychiatric symptoms) and biological profiles (i.e., metabolomics, inflammatory peptides [interleukin-6 and C-reactive protein], and brain-derived neurotrophic factor) to learn optimal dosing of TTI-0102 and to assess mechanism of action, and in Phase II (Year 2), to implement a feasibility trial in Veterans with a history of mild to moderate TBI and PTSD. In Phase I, 3 groups of 10 Veterans each will be randomly assigned to receive TTI-0102 2 grams/day, 4 grams/day, or placebo for 12 weeks. Baseline and post-treatment measures of objective cognition and subjective cognitive and neuropsychiatric symptoms will be administered, and plasma will be collected to measure the metabolomic, inflammatory, and protein biomarkers. In Phase II (Year 2), 12 different Veterans (6 per group) will be enrolled in a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of trial procedures. Participants in Phase II will be randomized to receive TTI-0102 (dose determined in Phase I) or placebo for 12 weeks as an adjunct to evidence-based CCT. The results of these double-blind, placebo-controlled trials will be used to plan a larger, fully-powered trial.
- Being tested
- TTI-0102, Placebo
- Keywords
- cognition, neurobehavioral symptoms, psychiatric symptoms
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTI-0102Drug
TTI-0102 is a cysteamine precursor.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TTI-0102 2 mg/day | Experimental | TTI-0102 2 mg/day Receives: Drug: TTI-0102 |
| TTI-0102 4 mg/day | Experimental | TTI-0102 4 mg/day Receives: Drug: TTI-0102 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cognition
Mean z-score of objective cognitive measures (Wechsler Adult Intelligence Scale-4th Edition Digit Span, WAIS-IV Coding, Hopkins Verbal Learning Test-Revised, Brief Visuospatial Memory Test-Revised, Delis-Kaplan Executive Function System Trails, D-KEFS Color-Word Interference, D-KEFS Verbal Fluency)
Measured: Change from 0 to 12 weeks
Secondary outcomes (10)
Subjective cognition
Mean z-score of subjective cognitive measures (Neuro-QOL Applied Cognition Executive Function, Neuro-QOL Applied Cognition General Concerns)
Measured: Change from 0 to 12 weeks
Neuropsychiatric symptoms
Mean z-score of subjective neuropsychiatric symptom measures (Neurobehavioral Symptom Inventory Patient Health Questionnaire-9, General Anxiety Disorder-7, Insomnia Severity Index, PTSD Checklist for DSM-5, WHO Disability Assessment Schedule 2.0)
Measured: Change from 0 to 12 weeks
high-sensitive C-reactive protein
high-sensitive C-reactive protein Plasma high sensitivity C-reactive protein (hsCRP) will be measured using the Quantikine HS ELISA kit. The assay sensitivity is 10 pg/ml, the standard range is linear to 100 pg/ml, and intra- and inter-assay CVs are 4.1% and 6.5%, respectively.
Measured: Change from 0 to 12 weeks
interleukin-6
interleukin-6 Plasma interleukin-6 (IL-6) will be measured using the Quantikine HS ELISA kit. The assay sensitivity is 0.70 pg/ml, the standard range is linear to 100 pg/ml, and intra- and inter-assay CVs are 2.6% and 4.5%, respectively.
Measured: change from 0 to 12 weeks
brain-derived neurotrophic factor
brain-derived neurotrophic factor We will use the Quantikine direct ELISA that selectively detects plasma levels of free brain-derived neurotrophic factor (BNDF) without measuring BDNF bound to blood protein that occurs with ELISAs that detect total BDNF. Specificity of this BDNF immunoassay has been further confirmed by using Western blots to detect BDNF levels in plasma that were also measured with the Quantikine BDNF ELISA. We will use our previously established protocol to increase ELISA sensitivity to <4 pg/ml and maximize performance by blocking nonspecific binding on the 96-well plate and optimizing incubation times and other variables for the Quantikine free BDNF ELISA. The intra- and inter-assay CVs for the BDNF ELISA are 4.4% and 7.8%, respectively.
Measured: change from 0 to 12 weeks
kynurenine metabolism
kynurenine metabolism Kynurenine metabolism will be assessed by broad-spectrum, targeted metabolomics using high performance liquid chromatography-tandem mass spectrometry (LC/MS/MS). Paired samples from each participant will be analyzed comparing baseline and TTI-0102-associated changes.
Measured: change from 0 to 12 weeks
sphingolipid metabolism
sphingolipid metabolism Sphingolipid metabolism will be assessed by broad-spectrum, targeted metabolomics using high performance liquid chromatography-tandem mass spectrometry (LC/MS/MS). Paired samples from each participant will be analyzed comparing baseline and TTI-0102-associated changes.
Measured: change from 0 to 12 weeks
purine metabolism
purine metabolism Purine metabolism will be assessed by broad-spectrum, targeted metabolomics using high performance liquid chromatography-tandem mass spectrometry (LC/MS/MS). Paired samples from each participant will be analyzed comparing baseline and TTI-0102-associated changes.
Measured: change from 0 to 12 weeks
eicosanoid metabolism
eicosanoid metabolism Eicosanoid metabolism will be assessed by broad-spectrum, targeted metabolomics using high performance liquid chromatography-tandem mass spectrometry (LC/MS/MS). Paired samples from each participant will be analyzed comparing baseline and TTI-0102-associated changes.
Measured: change from 0 to 12 weeks
sulfur amino acid metabolism
sulfur amino acid metabolism Sulfur amino acid metabolism will be assessed by broad-spectrum, targeted metabolomics using high performance liquid chromatography-tandem mass spectrometry (LC/MS/MS). Paired samples from each participant will be analyzed comparing baseline and TTI-0102-associated changes.
Measured: change from 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Oct 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Why it stopped: Funding withdrawn due to delay in FDA IND submission
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate TBIStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Phase 1, the investigators will determine whether TTI-0102 2 mg/day or 4 mg/day is more tolerated and/or more effective compared with placebo in Veterans with mild to moderate TBI and PTSD. In Phase 2, the investigators will determine the feasibility and acceptability of trial procedures involving TTI-0102 (dose determined in Phase 1) vs placebo in Veteran participants receiving Compensatory Cognitive Training.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elizabeth W. Twamley, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262895
- Sponsor's protocol ID
- N3323-P
- Other IDs
- I21RX003323-01
- Status last verified
- Oct 2021
- First submitted
- 5 Feb 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TTI-0102, a Cysteamine Precursor for Mild to Moderate TBI: Dosing and Feasibility Study
- ClinicalTrials.gov ID
- NCT04262895
- Acronym / sponsor ID
- N3323-P
- Keywords
- cognition, neurobehavioral symptoms, psychiatric symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn due to delay in FDA IND submission
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 10 Feb 2020 (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.
Traumatic brain injury (TBI) is a signature wound of the recent wars. How chronic TBI symptoms develop after a mild brain injury is not fully understood, but it is now thought that injury results in damage that reduces brain energy production, increases inflammation, and results in a leaky blood-brain barrier. Difficulties in daily function may persist in areas such as thinking (e.g., attention, learning, memory, planning, and problem-solving), pain (e.g., headache) and behavior (e.g., sleep, posttraumatic stress disorder, depression). No medications for TBI have been developed, so evidence-based cognitive rehabilitation interventions such as Compensatory Cognitive Training (CCT) are the mainstay of treatment. The investigators are proposing to study a medication, TTI-0102, that shows anti-inflammatory activity, as a potential adjunct treatment with CCT for Veterans with TBI-related symptoms. The investigators plan to first determine the best dose of TTI-0102 to use, and then to conduct a pilot study to test the feasibility and acceptability of combining TTI-0102 with CCT in Veterans with mild to moderate TBI and PTSD.
Detailed description
Approximately 12-23% of returning service members report a history of traumatic brain injury, mostly mild (mTBI). Post-concussive symptoms such as memory problems, irritability, and difficulty concentrating are common after TBI and may become chronic, interfering with successful return to duty or civilian reintegration, reducing quality of life, and increasing health care utilization for Veterans. In those whose TBI-related symptoms persist, there is accumulating evidence for increased morbidity (e.g., worse PTSD symptoms, chronic hypopituitarism, dementia), spurring efforts to improve diagnosis and intervention. Following a primary TBI injury, secondary injury and persistent symptoms may evolve through a complex cascade of events that culminate in inflammation, alterations in mitochondrial bioenergetics, and diminished blood brain barrier integrity, ultimately yielding a chronic disease state. To date, Veterans receiving strategy-based cognitive rehabilitation for TBI (CCT/CogSMART) have shown improvement in cognition and subjective neuropsychiatric symptoms. CCT is an evidence-based cognitive rehabilitation intervention emphasizing training in cognitive strategies to improve post-concussive symptoms, attention, learning/memory, and executive functioning. However, no pharmaceuticals have been developed for direct or adjunct-to CCT use to maximize treatment outcomes.
Given that inflammation has been observed in TBI, PTSD, and in co-occurring TBI/PTSD, it may be an important aspect of the TBI/PTSD disease state that could be manipulated to promote healing. The investigators are proposing to study TTI-0102, a cysteamine precursor that shows anti-inflammatory activity, as a potential adjunct to CCT for Veterans with TBI-related symptoms. TTI-0102 is a safe, easily administered, highly-water soluble compound that readily crosses the blood brain barrier. Compared with cysteamine, TTI-0102 degrades more slowly, dampening peak drug concentrations and sustaining drug plasma concentrations in a narrow therapeutic range. Developed to treat cystinosis, cysteamine is now believed to have potential for treatment of neurodegenerative disorders.
The goal of this proof of concept study is first, in Phase I (Year 1), to use symptom change (i.e., objective cognitive performance and subjective cognitive and neuropsychiatric symptoms) and biological profiles (i.e., metabolomics, inflammatory peptides [interleukin-6 and C-reactive protein], and brain-derived neurotrophic factor) to learn optimal dosing of TTI-0102 and to assess mechanism of action, and in Phase II (Year 2), to implement a feasibility trial in Veterans with a history of mild to moderate TBI and PTSD. In Phase I, 3 groups of 10 Veterans each will be randomly assigned to receive TTI-0102 2 grams/day, 4 grams/day, or placebo for 12 weeks. Baseline and post-treatment measures of objective cognition and subjective cognitive and neuropsychiatric symptoms will be administered, and plasma will be collected to measure the metabolomic, inflammatory, and protein biomarkers. In Phase II (Year 2), 12 different Veterans (6 per group) will be enrolled in a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of trial procedures. Participants in Phase II will be randomized to receive TTI-0102 (dose determined in Phase I) or placebo for 12 weeks as an adjunct to evidence-based CCT. The results of these double-blind, placebo-controlled trials will be used to plan a larger, fully-powered trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In Phase 1, the investigators will determine whether TTI-0102 2 mg/day or 4 mg/day is more tolerated and/or more effective compared with placebo in Veterans with mild to moderate TBI and PTSD. In Phase 2, the investigators will determine the feasibility and acceptability of trial procedures involving TTI-0102 (dose determined in Phase 1) vs placebo in Veteran participants receiving Compensatory Cognitive Training.
| Arm | Type | Receives |
|---|---|---|
| TTI-0102 2 mg/day | Experimental | Drug: TTI-0102TTI-0102 2 mg/day |
| TTI-0102 4 mg/day | Experimental | Drug: TTI-0102TTI-0102 4 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Veteran receiving care at the VA San Diego Healthcare system
- age 18-65
- history of mild to moderate TBI (loss of consciousness <24 hours; posttraumatic amnesia <7 days)
- documented impairment (>1 standard deviation below the mean) in at least one neuropsychological domain as determined by valid clinical neuropsychological testing using at least one performance validity test, i.e.:
Key exclusion criteria (7 listed)
- current alcohol and/or substance abuse or dependence
- high risk for homicide or suicide
- evidence of a significant uncontrolled/unstable medical illness or clinically significant surgery
- laboratory values that are significantly outside normal limits
- history of intolerance or hypersensitivity to cysteamine or penicillamine
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 |
|---|---|---|
| TTI-0102TTI-0102 is a cysteamine precursor. | Drug | TTI-0102 2 mg/day, TTI-0102 4 mg/day |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Objective cognition
Time frame: Change from 0 to 12 weeks
Mean z-score of objective cognitive measures (Wechsler Adult Intelligence Scale-4th Edition Digit Span, WAIS-IV Coding, Hopkins Verbal Learning Test-Revised, Brief Visuospatial Memory Test-Revised, Delis-Kaplan Executive Function System Trails, D-KEFS Color-Word Interference, D-KEFS Verbal Fluency)
10 secondary outcomes
Subjective cognition
Time frame: Change from 0 to 12 weeks
Neuropsychiatric symptoms
Time frame: Change from 0 to 12 weeks
high-sensitive C-reactive protein
Time frame: Change from 0 to 12 weeks
interleukin-6
Time frame: change from 0 to 12 weeks
brain-derived neurotrophic factor
Time frame: change from 0 to 12 weeks
kynurenine metabolism
Time frame: change from 0 to 12 weeks
sphingolipid metabolism
Time frame: change from 0 to 12 weeks
purine metabolism
Time frame: change from 0 to 12 weeks
eicosanoid metabolism
Time frame: change from 0 to 12 weeks
sulfur amino acid metabolism
Time frame: change from 0 to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared upon request.
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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.
Elizabeth W. Twamley, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TTI-0102 in people with Mild to Moderate TBI and Posttraumatic Stress Disorder, run by VA Office of Research and Development 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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 26 Oct 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective cognition (time frame: Change from 0 to 12 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 26 Oct 2021.