TTI-0102 for Veterans With TBI

• Status: Withdrawn
• Trial end date: 2021-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Cysteamine

Criteria

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