WithdrawnPhase 1/2

TTI-0102 for Veterans With TBI

Stopped: Funding withdrawn due to delay in FDA IND submission

United States0Started 2021-10-01

Plain-language 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. 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * working memory * learning, memory * executive functioning * DSM-5 diagnosis of PTSD based on the Clinician-Administered PTSD Scale Exclusion Criteria: * 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

What they're measuring

Objective cognition

Timeframe: Change from 0 to 12 weeks

Trial details

NCT IDNCT04262895

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2021-10-15