Journal of neurotrauma
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Journal of neurotrauma · Aug 2021
Randomized Controlled TrialCarbamazepine for Irritability and Aggression after Traumatic Brain Injury: A Randomized, Placebo-Controlled Study.
This study tested the hypothesis that carbamazepine (CBZ) reduces irritability/aggression among individuals >6 months post-traumatic brain injury (TBI). Seventy individuals were enrolled in a parallel-group, randomized, double-blind, placebo-controlled, forced-titration trial of CBZ (n = 35) versus placebo (n = 35). Participants were randomly assigned to receive CBZ or placebo 42 days with outcome assessed at baseline and Day 42. ⋯ Large placebo effects may have masked the detection of differences. Clinician rating metrics suggest benefit, and thus, CBZ should remain a treatment option for the experienced brain injury clinician. Data are provided that may aid treatment decisions.
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Journal of neurotrauma · Aug 2021
Randomized Controlled TrialA Randomized Controlled Trial of Local Delivery of a Rho-Inhibitor (VX-210) in Patients With Acute Traumatic Cervical Spinal Cord Injury.
Acute traumatic spinal cord injury (SCI) can result in severe, lifelong neurological deficits. After SCI, Rho activation contributes to collapse of axonal growth cones, failure of axonal regeneration, and neuronal loss. This randomized, double-blind, placebo-controlled phase 2b/3 study evaluated the efficacy and safety of Rho inhibitor VX-210 (9 mg) in patients after acute traumatic cervical SCI. ⋯ The pre-defined futility stopping rule was met, and the study was therefore ended prematurely. In the final analysis, the primary efficacy end-point was not met, with no statistically significant difference in change from baseline in upper-extremity motor score at 6 months after treatment between the VX-210 (9-mg) and placebo groups. This work opens the door to further improvements in the design and conduct of clinical trials in acute SCI.