UC joins trial testing three medications for TBI recovery

Laura Ngwenya, MD, PhD. Photo/UC Health.

Now, the University of Cincinnati is a site for the TRACK-TBI-APT clinical trial, testing three medications as potential new treatments for TBI.

The Phase 2 trial will randomize patients to receive the medications atorvastatin calcium, minocycline hydrochloride or candesartan cilexetil, or a matching placebo.

"These are drugs that are currently FDA-approved and used for different indications," said Laura Ngwenya, MD, PhD, trial site principal investigator, associate professor and vice chair of research in the Department of Neurosurgery in UC's College of Medicine, and director of the UC Gardner Neuroscience Institute's Neurotrauma Center. "They are well-known drugs that are safe, and previous trials have suggested these drugs may be effective in improving TBI recovery."

Patients will receive follow-up blood draws, imaging and additional tests over time to measure disability/recovery up to six months after the TBI. The researchers will also examine how blood-based and imaging biomarkers correlate with recovery.

Ngwenya noted this is what's known as an adaptive trial, meaning the protocols can be adjusted during the trial based on preliminary data. In this case, the medications that show promise for improving recovery will be prioritized and more patients will receive those medications as the trial progresses.

"This is the first TBI intervention trial to use biomarkers to help determine eligibility and to use an adaptive platform model," she said. "The adaptive model should allow sooner recognition of a potential treatment."

Approximately 35 to 40 patients are expected to enroll in the trial at UC, with approximately 672 patients planned to be enrolled across the trial's 18 sites.

"Because the drugs selected for the study are already FDA-approved, successful completion of this trial will allow immediate use in clinical practice to improve outcomes for patients with TBI," Ngwenya said.

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