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Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy

NCT06523725 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-04-24

No results posted yet for this study

Summary

This prospective double blind phase II study seeks to evaluate the safety and efficacy of BRC-003, a high CBD investigational product, in the treatment of refractory PTE (Post-Traumatic Epilepsy). The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B). This design aims to provide a thorough understanding of the investigational product's impact on seizure frequency, seizure severity, mood, anxiety, sleep, and quality of life.

Conditions

  • Post-traumatic Epilepsy

Interventions

DRUG

PO BRC-003 (High Cannabidiol Cannabis Extract)

The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B).

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Biopharmaceutical Research Company

    collaborator UNKNOWN

  • Dr. Paul Lyons

    lead OTHER

Principal Investigators

  • Paul D Lyons, MD. PhD · Valley Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-04-15
Completion
2025-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06523725 on ClinicalTrials.gov