ADHDPhase 2NCT06673368
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
A Phase 2 study testing NRCT-101SR, NRCT-202XR in people with ADHD, run by Neurocentria, Inc. at 5 sites in United States.
Trial summary
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- NRCT-101SR, NRCT-202XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Feb 2025to 15 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston Clinical Trials LLC
Boston, Massachusetts, 02131
iResearch Atlanta
Decatur, Georgia, 30030
Center For Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Accel Research Site-Maitland Clinical Research Unit
Maitland, Florida, 32751
CenExel iRS - iResearch Savannah
Savannah, Georgia, 31405
About this study
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
Read the detailed description
A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD.
Subjects' enrollment will be conducted in two stages.
In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio):
Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR
In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR.
The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.
- Conditions
- ADHD
- Being tested
- NRCT-101SR, NRCT-202XR
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRCT-101SR, NRCT-202XRDrug
NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | NRCT-101SR and low dose NRCT-202XR Receives: Drug: NRCT-101SR, NRCT-202XR |
| Arm 2 | Active comparator | NRCT-101SR placebo and high dose NRCT-202XR Receives: Drug: NRCT-101SR, NRCT-202XR |
| Arm 3 | Active comparator | NRCT-101SR placebo and low dose NRCT-202XR Receives: Drug: NRCT-101SR, NRCT-202XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-S
Measured: 6 weeks
SDSE-RS
Measured: 6 weeks
Secondary outcomes (3)
CBRS-P
and academic problems in children between the ages of 6 and 18 years and are reported by parents.
Measured: 6 weeks
DPREMB-R
Measured: 6 weeks
ADHD-RS-5
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start25 Feb 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Bar-Klein, PhD, Study director, Neurocentria, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673368
- Sponsor's protocol ID
- NC-022A
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06673368
- Acronym / sponsor ID
- NC-022A
- Conditions
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Neurocentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
Detailed description
A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD.
Subjects' enrollment will be conducted in two stages.
In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio):
Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR
In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR.
The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: NRCT-101SR, NRCT-202XRNRCT-101SR and low dose NRCT-202XR |
| Arm 2 | Active comparator | Drug: NRCT-101SR, NRCT-202XRNRCT-101SR placebo and high dose NRCT-202XR |
| Arm 3 | Active comparator | Drug: NRCT-101SR, NRCT-202XRNRCT-101SR placebo and low dose NRCT-202XR |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRCT-101SR, NRCT-202XRNRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
CGI-S
Time frame: 6 weeks
SDSE-RS
Time frame: 6 weeks
3 secondary outcomes
CBRS-P
Time frame: 6 weeks
DPREMB-R
Time frame: 6 weeks
ADHD-RS-5
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Bar-Klein, PhD study director
Neurocentria, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRCT-101SR, NRCT-202XR in people with ADHD, run by Neurocentria, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGI-S (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.