NRCT-101-SR for ADHD

Recruiting at 8 trial locations

Overseen By Exec Director, Research & Strategy

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Neurocentria, Inc.

Must not be taking: Stimulants, Non-stimulants

Disqualifiers: Severe psychiatric symptoms, Substance abuse, Cardiac disease, 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: 7

Duration: 6 weeks

223 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medication called NRCT-101SR to see if it helps adults with ADHD. Participants will take the medication regularly, and researchers will measure its effectiveness by looking at math test scores and symptom ratings before and after treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking stimulant medications at least 2 weeks and non-stimulant medications at least 3 weeks before joining. Other medications must be at stable doses for at least 30 days before the trial and should remain stable during the trial.

What data supports the effectiveness of the drug NRCT-101-SR for ADHD?

The study on reboxetine, a drug similar to NRCT-101-SR, showed effectiveness in children with ADHD who did not respond well to other treatments, suggesting potential benefits for NRCT-101-SR. Additionally, the use of brexpiprazole combined with stimulants in treatment-resistant ADHD highlights the potential for combination therapies, which may be relevant to NRCT-101-SR's effectiveness. ^{1 2 3 4 5}

What safety data exists for NRCT-101-SR or similar treatments for ADHD?

The safety of ADHD medications, including non-stimulants, is not fully known, with concerns about both minor and serious side effects like suicidal thoughts and sudden cardiac death. Monitoring and patient education are important, as some patients may experience milder side effects, but serious adverse events are still reported to a small degree. ^{6 7 8 9 10}

How does the drug NRCT-101SR differ from other ADHD treatments?

NRCT-101SR is unique because it may target the nicotinic acetylcholine receptor (nAChR) system, which is not a focus of current approved ADHD medications. This approach is based on the potential benefits of nicotinic agents in improving attention and cognitive function, offering a novel mechanism compared to traditional stimulant and nonstimulant treatments. ^{11 12 13 14 15}

Research Team

Guosong Liu, M.D., Ph.D.

Principal Investigator

Neurocentria, Inc.

Eligibility Criteria

Adults over 18 with ADHD diagnosed by DSM-5 criteria, who have not taken ADHD medication recently. They must be fluent in English, have completed at least 10 years of education, and weigh between 50 kg and 105 kg. Participants should be able to see and hear well enough for cognitive tests.

Inclusion Criteria

My weight is between 50 and 105 kg, and my lean body mass is 75 kg or less.

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

Hearing and Vision ability sufficient to complete cognitive testing, in investigator's opinion

Exclusion Criteria

Currently living in an institutional facility such as a nursing home

My family has a history of sudden heart-related deaths or irregular heartbeats.

My medication doses have been stable for the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

1 visit (in-person)

Orientation

Participants complete an LC Orientation Visit within 8 days prior to Baseline

1 week

1 visit (in-person)

Baseline

Baseline evaluations are conducted before randomization

1 day

1 visit (in-person)

Treatment

Participants receive NRCT-101SR or placebo for 6 weeks with regular assessments

6 weeks

3 visits (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (virtual)

Treatment Details

Interventions

• NRCT-101SR
• Placebo

Trial Overview The trial is testing NRCT-101SR's effectiveness and safety against a placebo in adults with ADHD. Patients will either receive the actual drug or a placebo to compare results.

Participant Groups

Group I: NRCT-101SR Experimental Treatment 1 Intervention

Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily

Group II: Matching Placebo Placebo Group 1 Intervention

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+

Findings from Research

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]

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]

ADHD is a common and treatable condition, but current clinical trials often exclude patients with comorbidities or non-compliance, which limits our understanding of treatment effectiveness in real-world settings.

To improve ADHD treatment outcomes, it is essential to conduct effectiveness studies that consider factors like patient compliance, comorbid conditions, and individual preferences, as these greatly influence treatment success and persistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness outcomes in attention-deficit/hyperactivity disorder. Weiss, MD., Gadow, K., Wasdell, MB.[2015]

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]

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 review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

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]

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]

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]

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 of 297 children and adolescents with ADHD, atomoxetine was found to be significantly more effective than placebo in reducing ADHD symptoms and improving social and family functioning over an 8-week period.

The study demonstrated a graded dose-response, with doses of 1.2 mg/kg/day and 1.8 mg/kg/day showing similar efficacy, suggesting that 1.2 mg/kg/day may be the optimal starting dose for treatment, while adverse events were minimal, with discontinuations due to side effects being less than 5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study. Michelson, D., Faries, D., Wernicke, J., 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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Reboxetine for ADHD in children non-responders or with poor tolerance to methylphenidate: a prospective long-term open-label study. [2018]

2. England 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The Use of Brexpiprazole Combined With a Stimulant in Adults With Treatment-Resistant Attention-Deficit/Hyperactivity Disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness outcomes in attention-deficit/hyperactivity disorder. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Updates in Pharmacologic Strategies in Adult Attention-Deficit/Hyperactivity Disorder. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. [2021]

8. Ireland 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Use of serotonin norepinephrine reuptake inhibitors in the treatment of attention-deficit hyperactivity disorder in pediatrics. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled phase 2 study of α4β2 agonist ABT-894 in adults with ADHD. [2021]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Drug therapy for adults with attention-deficit hyperactivity disorder. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study. [2022]

14. England 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. [2021]

15. New Zealand pubmed.ncbi.nlm.nih.gov

Targeting the nicotinic cholinergic system to treat attention-deficit/hyperactivity disorder: rationale and progress to date. [2022]