NRCT-101SR for ADHD

(ADHD Trial)

Recruiting at 15 trial locations

Overseen By Kimball Johnson, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Neurocentria, Inc.

Disqualifiers: Severe psychiatric symptoms, Seizures, Substance abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NRCT-101SR, a potential drug, to evaluate its effectiveness and safety for teenagers aged 13-17 with ADHD. The study compares the effects of NRCT-101SR with a placebo, a pill that resembles the medicine but contains no active ingredients. Teens diagnosed with ADHD who experience significant symptoms, such as restlessness and difficulty focusing, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify that you must stop taking your current medications. However, any allowed medications must be at stable doses for at least 30 days before screening and should remain stable during the trial.

Is there any evidence suggesting that NRCT-101SR is likely to be safe for humans?

Research has shown that NRCT-101SR was safe in earlier studies. In adult trials, participants tolerated it well, and no serious side effects occurred. This suggests it might also be safe for teenagers. Adults experienced some common side effects, such as mild headaches and slight nausea, but these were not serious. As the treatment is in advanced testing stages, extensive safety information is already available. So far, the results are promising, and the treatment appears safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

Researchers are excited about NRCT-101SR for ADHD because it offers a potential new approach to managing the condition. Unlike current treatments like stimulants or non-stimulants that primarily target neurotransmitters such as dopamine and norepinephrine, NRCT-101SR appears to work differently, potentially offering benefits for those who don't respond well to existing medications. Additionally, the dosage flexibility of up to 2,000 mg/day could allow for personalized treatment plans, which might improve effectiveness and reduce side effects. This novel approach could mean better outcomes for individuals with ADHD, addressing a significant need in current treatment options.

What evidence suggests that NRCT-101SR might be an effective treatment for ADHD?

Research has shown that NRCT-101SR, which participants in this trial may receive, might help treat ADHD. In studies with adults, NRCT-101SR led to noticeable improvements in ADHD symptoms compared to a placebo. This treatment affects certain brain areas related to attention and focus. Early results are promising, showing better attention and thinking skills, especially in children. While more information is needed for teenagers, these early findings suggest NRCT-101SR could also help teens with ADHD. ^{1 3 5 6 7}

Who Is on the Research Team?

Guy Bar-Klein, PhD

Principal Investigator

Neurocentria, Inc.

Are You a Good Fit for This Trial?

This trial is for young people aged 13-17 who have been diagnosed with ADHD. The specific eligibility criteria to join the study are not provided, but typically participants must meet certain health standards and cannot be taking conflicting medications.

Inclusion Criteria

I have been diagnosed with ADHD according to DSM-5.

I am between 13 and 17 years old.

ADHD-related symptoms - ADHD-RS-5 ≥ 26 in screening and baseline

Exclusion Criteria

Investigators and their immediate family members are not permitted to participate in the study

My kidney function is below normal levels.

I am not pregnant, breastfeeding, or if capable of becoming pregnant, I agree to use birth control as required.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NRCT-101SR or placebo for 6 weeks to evaluate safety and efficacy

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with NRCT-101SR for an additional 6 weeks

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NRCT-101SR

Trial Overview The trial is testing NRCT-101SR, a medication intended to treat ADHD in adolescents. Participants will either receive NRCT-101SR or a placebo (a substance with no therapeutic effect) to compare effectiveness and safety.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

Up to 2,000 mg/day

Group II: Control Arm Placebo Group 1 Intervention

Matching placebo

NRCT-101SR is already approved in United States for the following indications:

Approved in United States as NRCT-101SR for:

• Attention Deficit Hyperactivity Disorder (ADHD)

Who Is Running the Clinical Trial?

Neurocentria, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Published Research Related to This Trial

In a study of 18 prepubertal boys with both ADHD and conduct disorder, 61% showed marked improvement after receiving clonidine following unsuccessful trials with other medications.

Clonidine was generally well tolerated, with only temporary sedation noted in some cases, suggesting it could be a viable alternative treatment for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clonidine therapy for comorbid attention deficit hyperactivity disorder and conduct disorder: preliminary findings in a children's inpatient unit. Schvehla, TJ., Mandoki, MW., Sumner, GS.[2019]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

Venlafaxine has shown improvement in ADHD symptoms in pediatric patients aged 6 to 17 years, based on trials lasting 2 to 6 weeks, making it a potential alternative treatment when other medications are not effective or tolerated.

Duloxetine demonstrated minimal efficacy in treating ADHD symptoms at a dose of 60 mg/d over 6 weeks, and due to limited data, it cannot be recommended as a treatment option for ADHD in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of serotonin norepinephrine reuptake inhibitors in the treatment of attention-deficit hyperactivity disorder in pediatrics. Park, P., Caballero, J., Omidian, H.[2022]

FDA-approved stimulant and nonstimulant medications can significantly improve ADHD symptoms in adults, highlighting the importance of pharmacotherapy in managing this condition.

There are ongoing investigations into new medications with unique mechanisms of action to address limitations in current treatments, especially for patients with comorbid conditions like substance use or cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates in Pharmacologic Strategies in Adult Attention-Deficit/Hyperactivity Disorder. Anbarasan, D., Safyer, G., Adler, LA.[2022]

A study analyzing adverse events from nonstimulant ADHD medications (atomoxetine, clonidine, and guanfacine) found that common side effects include ineffectiveness (up to 14.15%), fatigue (8.93%), and somnolence (up to 10.16%).

Suicidal ideation was reported among users of all three medications, highlighting the importance of monitoring and educating patients about potential serious side effects, even though they occur less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. Pang, L., Sareen, R.[2021]

In a study involving 236 adults with treatment-resistant ADHD, adjunctive treatment with brexpiprazole did not show significant improvement in primary ADHD symptoms compared to placebo, as measured by the Conners' Adult ADHD Rating Scale.

However, there was a trend indicating potential benefits of brexpiprazole in reducing emotional dysregulation symptoms in prior stimulant nonresponders, suggesting that future research should focus on this aspect of ADHD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Brexpiprazole Combined With a Stimulant in Adults With Treatment-Resistant Attention-Deficit/Hyperactivity Disorder. Reimherr, FW., Gift, TE., Steans, TA., et al.[2022]

In a study of 338 children aged 6-11 with ADHD treated with atomoxetine for up to 1 year, significant improvement in ADHD symptoms was observed within approximately 3.7 weeks, indicating a relatively quick response to treatment.

However, full remission of symptoms took longer, with a median time of about 14.3 weeks, suggesting that while atomoxetine can lead to noticeable improvements, achieving complete symptom relief may require several months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. Dickson, RA., Maki, E., Gibbins, C., et al.[2021]

In a study involving 243 adults with ADHD, the novel α4β2 NNR agonist ABT-894 (4 mg twice daily) showed significant improvement in ADHD symptoms compared to placebo, indicating its efficacy as a treatment option.

ABT-894 was well tolerated across all doses tested, suggesting a favorable safety profile, and further research is encouraged to explore higher doses and its potential in ADHD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled phase 2 study of α4β2 agonist ABT-894 in adults with ADHD. Bain, EE., Robieson, W., Pritchett, Y., et al.[2021]

In a study involving 206 children aged 8-14 with ADHD, AKL-T01, an app and video-game-based treatment, significantly improved ADHD-related impairment after 4 weeks of use, regardless of whether the children were on stimulant medication or not.

The treatment was well-tolerated with no serious adverse events reported, indicating it is a safe adjunct therapy for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. Kollins, SH., Childress, A., Heusser, AC., et al.[2021]

The NEWROFEED study is evaluating the efficacy of a personalized neurofeedback (NF) training device for children with ADHD, comparing it to the standard medication methylphenidate, involving 179 participants aged 7 to 13 across 13 clinical centers in Europe.

This study is innovative as it personalizes NF training based on each child's brain activity patterns and allows for at-home training, potentially increasing accessibility and convenience for families while being monitored by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD. Bioulac, S., Purper-Ouakil, D., Ros, T., et al.[2020]

Clonidine extended-release and clonidine have been found to be effective in treating ADHD symptoms in children and adolescents, based on a review of ten clinical trials, with nine showing positive results.

Both forms of clonidine were reported to be well tolerated, with common side effects including drowsiness and fatigue, but there are concerns about potential serious cardiac side effects, highlighting the need for further research on long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of clonidine and clonidine extended-release in the treatment of children and adolescents with attention deficit and hyperactivity disorders. Ming, X., Mulvey, M., Mohanty, S., et al.[2021]

In a 16-week study involving 48 children with mental retardation and ADHD, atomoxetine significantly improved ADHD symptoms, as shown by a notable reduction in Clinical Global Impression Severity scores and other ADHD rating scales.

While 31% of participants experienced mild adverse events, primarily irritability, the overall tolerability of atomoxetine was acceptable, suggesting it can be a useful treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atomoxetine for attention deficit hyperactivity disorder in mental retardation. Fernández-Jaén, A., Fernández-Mayoralas, DM., Calleja Pérez, B., et al.[2015]

In a phase 2 pilot study involving 160 participants with ADHD, ABT-089 (80 mg once daily) was generally well tolerated, with no significant safety concerns or clinically significant adverse events reported.

However, the study found no statistically significant treatment effects for either the 40 mg or 80 mg doses of ABT-089 compared to placebo, indicating that this dosage may not be effective for reducing ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot study of the efficacy and safety of ABT-089, a novel α4β2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. Bain, EE., Apostol, G., Sangal, RB., et al.[2013]

Atomoxetine is a safe and effective alternative treatment for ADHD in children and adolescents, showing significant reductions in ADHD symptoms in clinical trials with a mean dose of 1.5 mg/kg/day.

The drug has a favorable safety profile, with only 2.8% of participants discontinuing due to adverse effects, which primarily included gastrointestinal symptoms and decreased appetite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atomoxetine: a new treatment for Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescents]. Purper-Ouakil, D., Fourneret, P., Wohl, M., et al.[2020]

ABT-089, a novel treatment for ADHD in children, did not show any significant improvement compared to placebo in reducing ADHD symptoms, as measured by the ADHD-RS-IV Total Score in two studies involving 393 children aged 6 to 12.

The safety profile of ABT-089 was similar to that of placebo, with no significant differences in adverse events or other safety measures, indicating it was generally well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. Wilens, TE., Gault, LM., Childress, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05683249

NCT05683249 | Study to Evaluate NRCT-101SR in Adult ... 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.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05683249/study-to-evaluate-nrct-101sr-in-adult-attention-deficit-hyperactivity-disorder-adhd

Study to Evaluate NRCT-101SR in Adult Attention Deficit ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06215144

Study to Evaluate NRCT-101SR in Pediatric Subjects with ... The primary analysis will be on effects of 6-week treatment of NRCT-101SR versus placebo on performance (PERMP) in subjects with ADHD. Official Title. A Phase 2 ...

4. withpower.com withpower.com/trial/phase-2-and-3-attention-deficit-disorder-with-hyperactivity-2023-beb84

NRCT-101-SR for ADHD · Info for Participants In a study involving 243 adults with ADHD, the novel α4β2 NNR agonist ABT-894 (4 mg twice daily) showed significant improvement in ADHD symptoms compared to ...

5. synapse.patsnap.com synapse.patsnap.com/article/whats-the-latest-update-on-the-ongoing-clinical-trials-related-to-attention-deficit-disorder-with-hyperactivity

What's the latest update on the ongoing clinical trials ... This approach is especially promising for children, as studies have shown tangible improvements in objective measures of attention and cognitive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06215144

Study to Evaluate NRCT-101SR in Pediatric Subjects with ... The primary analysis will be on effects of 6-week treatment of NRCT-101SR versus placebo on performance (PERMP) in subjects with ADHD. Official Title. A Phase 2 ...

7. trialx.com trialx.com/clinical-trials/listings/296025/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-deficithyperactivity-disorder/

A Phase 2 Randomized Double-Blind, Parallel, Adaptive ... A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR with NRCT-202XR ...