CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 223 enrolled
Drug / intervention
NRCT-101-SR +1 moredrug
Likely dose
NRCT-101SR 500 mg four times daily (subjects ≥50 kg LBM) or 375 mg four times daily (subjects <50 kg LBM)AI-extracted
Key inclusion· 6
  • ✓Age ≥18 years at screening
  • ✓Primary diagnosis of ADHD confirmed by DSM-5 criteria using MINI
  • ✓AISRS score ≥26 at both screening and baseline, with ≤25% change between visits (exception: subjects stopping ADHD meds may have >25% increase)
  • ✓CGI-S score ≥4 at baseline
Key exclusion· 10
  • ✕Lifetime history of severe psychiatric disorders (major depression with hospitalization, bipolar disorder, schizophrenia, schizoaffective disorder, hallucinations, delusions) or severe comorbidities (PTSD, severe OCD) that contraindicate treatment or confound assessment
  • ✕History of seizures (except infantile febrile seizures), any tic disorder (except transient tic with no episodes ≥1 year), or Tourette's Disorder
  • ✕Recent substance abuse/dependence history (within past 1 year, excluding stable nicotine use)
  • ✕Active suicidal ideation with intent to act (C-SSRS items 4–5) in past 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05683249
NCT05683249Phase 3Completed
CompareCT.gov

Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder

Neurocentria, Inc.·interventional·Posted Jan 13, 2023·Updated Jun 3, 2025

In Brief

A Phase 3 clinical trial evaluating NRCT-101-SR and Placebo for ADHD. Completed, enrolled 223 participants across 9 sites.

Detailed Summary

The goal of this clinical trial is to evaluate the efficacy and safety of NRCT-101SR compared to placebo in adult patients with ADHD aged 18 years and older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJan 13, 2023
Enrollment StartFeb 25, 2023
Primary CompletionJan 17, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.5 years ago

Interventions

NRCT-101-SRdrug

NRCT-101SR is a sustained release formulation. Subjects ≥ 50 kg LBM receive a total of four 500 mg tablets/day and subjects \< 50kg LBM receive a total of four 375 mg tablets per day.

Placebodrug

Matching placebo