150 Participants Enrolled: A Landmark Milestone in Traumatic Brain Injury Drug Treatment Research
We are thrilled to share that our trial has successfully enrolled and randomized 150participants to a treatment or placebo arm across 18 participating sites. This achievement reflects the tireless commitment of site staff, the coordinating Sponsor and CHeT/CTCC, and—most importantly—the patients and families who have elected to participate in the study, thereby contributing to the advancement of research in traumatic brain injury treatment.
Why this Milestone Matters
Enrolling and randomizing 150 participants demonstrates that rigorous trials are achievable in a population historically afflicted by low rates of follow-up and high symptom burden—bringing us closer to discovering and validating treatments that meaningfully improve recovery and quality of life.
Over 75% of clinical trials in this heterogenous population have been unsuccessful, largely due to a lack of clinically-relevant inclusion criteria, disease heterogeneity, and crude follow-up endpoints. Reaching 150 participants (and counting!) shows that coordinated enrollment is feasible across diverse sites and institutions and reflects our trial network’s commitment to patients and our shared mission.
The Network Behind the Number
We have navigated challenges of an interventional clinical trial in TBI: medication administration with narrow tolerance windows, harmonization of clinical and research interests, objective eligibility criteria, and a multitude of patient- and technology-related issues. The clear and consistent communication from all sites has been a defining strength of this trial and helps to ensure protocol adherence. We encourage each site and study team member to recognize this milestone as a shared accomplishment. Each datapoint, question, and suggestion is integral to the advancement of patient care.