The Study of Brave-LC LDN Treatment Trial
NCT07916259, Phase 3, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Study of Brave-LC LDN Treatment Trial | ClinicalTrials.gov |
| NCT number | NCT07916259 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 1,300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ClinicalTrials.gov |
| Conditions | Post-acute COVID-19 Syndrome | ClinicalTrials.gov |
| Interventions | naltrexone, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS) total score. | Baseline to 16 weeks after randomization | The Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS) contains 18 Likert-type items and is scored from 0 to 100; higher scores represent lower levels of fatigue. | ClinicalTrials.gov |
| Secondary | Change from baseline Delis-Kaplan Executive Function System (D-KEFS) Category Fluency t-score | Baseline to 16 weeks after randomization | The D-KEFS Verbal Fluency Category Fluency condition measures verbal fluency and executive function. Participants generate as many words as possible beginning with a specified letter within a fixed time. Performance score is scored by the number of correct words and interpreted using age-appropriate normative data. This outcome applies to English-speaking participants aged 8 to 25 years. | ClinicalTrials.gov |
| Secondary | Change from baseline Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency t-score | Baseline to 16 weeks after randomization | The D-KEFS Verbal Fluency Letter Fluency condition measures verbal fluency and executive function. Participants generate as many words as possible beginning with a specified letter within a fixed time. Performance score is scored by the number of correct words and interpreted using age-appropriate normative data. This outcome applies to English-speaking participants aged 8 to 25 years. | ClinicalTrials.gov |
| Secondary | Change from baseline in Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2) Global Executive Composite t-score | Baseline to 16 weeks after randomization | The BRIEF-2 is a standardized questionnaire assessing executive function and self-regulation in participants aged 6 to 17 years. Scores are interpreted using age- and sex-appropriate normative data. Higher scores indicate greater impairment in executive functioning. | ClinicalTrials.gov |
| Secondary | Change from baseline in Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2A) Global Executive Composite t-score | Baseline to 16 weeks after randomization | The BRIEF-2A is a standardized 75-item self-report assessment of executive functioning in participants aged 18 years and older. Scores are interpreted using age- and sex-appropriate normative data. Higher scores indicate greater impairment in executive functioning. | ClinicalTrials.gov |
| Secondary | Change from baseline in Conners Continuous Performance Test-Third Edition (CPT-3) Detectability t-score. | Baseline to 16 weeks after randomization | The CPT-3 is a computerized assessment of sustained attention and response control for participants aged 8 years and older. Performance is automatically recorded and interpreted using age-appropriate normative data. | ClinicalTrials.gov |
| Secondary | Change from baseline in Conners Continuous Performance Test-Third Edition (CPT-3) Hit Reaction Time t-score | Baseline to 16 weeks after randomization | The CPT-3 is a computerized assessment of sustained attention and response control for participants aged 8 years and older. Performance is automatically recorded and interpreted using age-appropriate normative data. | ClinicalTrials.gov |
| Secondary | Change from baseline in Connors Kiddie Continuous Performance Test (K-CPT-2) Detectability t-score. | Baseline to 16 weeks after randomization | The K-CPT-2 Computerized assessment of sustained attention and response control for participants aged 6 to 7 years. Performance is automatically recorded and interpreted using age-appropriate normative data. | ClinicalTrials.gov |
| Secondary | Change from baseline in Connors Kiddie Continuous Performance Test (K-CPT-2) Hit Reaction Time t-score | Baseline to 16 weeks after randomization | The K-CPT-2 Computerized assessment of sustained attention and response control for participants aged 6 to 7 years. Performance is automatically recorded and interpreted using age-appropriate normative data. | ClinicalTrials.gov |
| Secondary | Change from baseline in Developmental Neuropsychological Assessment (NEPSY-II) Semantic Word Generation Scaled score. | Baseline to 16 weeks after randomization | The NEPSY-II Word Generation subtest measures verbal fluency and executive function. Participants generate words within semantic category during 60-second time limit. Performance is scored by the number of correct words\[TS3.1\] and interpreted using age-appropriate normative data. This outcome applies to English-speaking participants aged 6 to 7 years. | ClinicalTrials.gov |
| Secondary | Change from baseline in Digit Span-Wechsler Intelligence Scale for Children-Fifth Edition (WISC-V) t-score. | Baseline to 16 weeks after randomization | The WISC-V Digit Span subtest assesses attention and working memory in participants aged 6 to 15 years. Raw scores are based on Digit Span Forward, Backward, and Sequencing tasks and are interpreted using age-appropriate normative data. | ClinicalTrials.gov |
| Secondary | Change from baseline in Digit Span-Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV) t-score. | Baseline to 16 weeks after randomization | The WISC-IV Digit Span subtest assesses attention and working memory in participants aged 16 years and older. Raw scores are based on Digit Span Forward, Backward, and Sequencing tasks and are interpreted using age-appropriate normative data. | ClinicalTrials.gov |
| Secondary | Change from baseline in Functional Disability Inventory (FDI) total score. | Baseline to 16 weeks after randomization | The Functional Disability Inventory (FDI) contains 15 items rated from 0 ('no trouble') to 4 ('impossible'). Total scores range from 0 to 60. Higher scores represent greater functional disability and more impairment in daily functioning. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient Global Impression of Severity (PGI-S) | Baseline to 16 weeks after randomization | The Patient Global Impression of Severity (PGI-S) is a single-item questionnaire rated on a 5-point Likert scale from 1 ('None') to 5 ('Very severe'). Higher scores reflect greater perceived illness or symptom severity. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Pain Intensity Scale t-score in participants aged 18 to 25 years. | Baseline to 16 weeks after randomization | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale asks about pain over the past 7 days. Items are rated on a 5-point scale from 1 ('not at all') to 5 ('very much'). Results are reported as T-scores. Higher scores representing greater pain intensity. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Pain Interference Scale t-score in participants aged 18 to 25 years. | Baseline to 16 weeks after randomization | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale asks how pain affects activities, mood, and social participation over the past 7 days. Items are rated on a 5-point scale from 1 ('not at all') to 5 ('very much'). Results are reported as T-scores. Higher scores representing greater pain interference. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent-Proxy Pain Intensity Scale t-score in participants aged 6 to 7 years. | Baseline to 16 weeks after randomization | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity scale asks about pain over the past 7 days. Items are rated on a 5-point scale from 1 ('not at all') to 5 ('very much'). Results are reported as T-scores, with higher scores representing greater pain intensity. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent-Proxy Pain Interference Scale t-score in participants aged 6 to 7 years. | Baseline to 16 weeks after randomization | The Patient-Reported Outcomes Measurement Information System (PROMIS) Parent-Proxy Pain Interference Scale asks how pain affects activities, mood, and social participation over the past 7 days. Items are rated on a 5-point scale from 1('not at all') to 5('very much'). Results are reported as T-scores. Higher scores representing greater pain interference. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Intensity Scale t-score in participants aged 8 to 17 years. | Baseline to 16 weeks after randomization | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Intensity Scale asks about pain over the past 7 days. Items are rated on a 5-point scale from 1 ('not at all') to 5 ('very much'). Results are reported as T-scores. Higher scores representing greater pain intensity. | ClinicalTrials.gov |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale t-score in participants aged 8 to 17 years. | Baseline to 16 weeks after randomization | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference scale asks how pain affects activities, mood, and social participation over the past 7 days. Items are rated on a 5-point scale from 1 ('not at all') to 5 ('very much'). Results are reported as T-scores. Higher scores representing greater pain interference. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| OT2HL156812 | ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center | THOMAS, SONIA M; NOLEN, TRACY L | RESEARCH TRIANGLE INSTITUTE | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2020 to 2024 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)