Frontlight ResearchEarly access
TerminatedPhase 2
A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder
Key facts
- Who runs it
- Neurocentria, Inc.
- Where
- Boston, Decatur, Las Vegas, Maitland, and Savannah, United StatesSee the 5 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 2 people enrolled
- Started
- 25 Feb 2025
- Ended
- 15 Jul 2025
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- NRCT-101SR, NRCT-202XR
- Record updated
- 15 January 2026
- Why it stopped
- Slow enrollment
Who can take part
- Age
- 13 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Other criteria
- Male or female, 13-17 years of age at screening
- Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes
- Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline
- Has side effects identified using SDSE-RS at Screening and Baseline
- CGI-S ≥ X (blinded) at Screening and Baseline
- Must be fluent in English and communicate effectively with others
- Both subject and parent/guardian willing and able to give informed assent/consent
- Parent/guardian willing to serve as informant
Where in United States
- Boston Clinical Trials LlcBoston, United States
- iResearch AtlantaDecatur, United States
- Center for Psychiatry and Behavioral MedicineLas Vegas, United States
- Accel Research Site-Maitland Clinical Research UnitMaitland, United States
- CenExel iRS (iResearch Savannah)Savannah, United States
About the trial
What the trial wants to find out
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
The 3 groups in the trial
- Arm 1Existing treatment, for comparison
NRCT-101SR and low dose NRCT-202XR
Treatment: NRCT-101SR, NRCT-202XR
- Arm 2Existing treatment, for comparison
NRCT-101SR placebo and high dose NRCT-202XR
Treatment: NRCT-101SR, NRCT-202XR
- Arm 3Existing treatment, for comparison
NRCT-101SR placebo and low dose NRCT-202XR
Treatment: NRCT-101SR, NRCT-202XR
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 January 2026