Clinical Trial: The Study of Brave-LC LDN Treatment Trial

U.S., Nov. 5 -- ClinicalTrials.gov registry received information related to the study (NCT07916259) titled 'The Study of Brave-LC LDN Treatment Trial' on Oct. 29.

Brief Summary: This is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of a 16-week course of low-dose naltrexone (LDN) in approximately 1,300 participants aged 6 to 25 years with fatigue associated with Long COVID. Participants will be enrolled across three age cohorts (6-11, 12-17, and 18-25 years) and randomized 1:1 to receive LDN capsules or matching placebo capsules. LDN will be initiated at 1.5 mg daily and titrated weekly to a maximum tolerated dose of up to 4.5 mg daily. Randomization will be stratified by age cohort, and pa...