NRCT-101SR + NRCT-202XR for ADHD

Recruiting at 5 trial locations

Overseen By Guy Bar-Klein, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurocentria, Inc.

Must be taking: ADHD medication

Disqualifiers: Non-ADHD, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.

Will I have to stop taking my current medications?

The trial requires participants to be taking ADHD medication regularly, so you will not have to stop your current medications.

What data supports the effectiveness of the drug NRCT-101SR + NRCT-202XR for ADHD?

Research on similar drugs, like atomoxetine, shows they are effective in treating ADHD symptoms in children, adolescents, and adults. Atomoxetine, a non-stimulant drug, has been shown to improve core ADHD symptoms and overall functioning, suggesting that similar treatments may also be effective. ^{1 2 3 4 5}

What safety data exists for NRCT-101SR + NRCT-202XR for ADHD?

The safety of atomoxetine, a non-stimulant medication for ADHD, has been studied in over 4000 patients, showing common side effects like fatigue and sleepiness, with some reports of suicidal thoughts. In adults, atomoxetine was associated with mild increases in heart rate and blood pressure, but no increased risk of serious side effects. Guanfacine, another non-stimulant, has been studied for safety in adults with ADHD, but specific safety data for NRCT-101SR + NRCT-202XR is not available. ^{6 7 8 9 10}

Research Team

Guy Bar-Klein, PhD

Principal Investigator

Neurocentria, Inc.

Eligibility Criteria

This trial is for boys and girls aged 13-17 with a confirmed diagnosis of ADHD, who have been on ADHD medication consistently. They must be experiencing side effects from their current treatment, speak English fluently, and both the participant and their guardian must consent to join.

Inclusion Criteria

I have been taking ADHD medication regularly for over 6 weeks.

My parent/guardian agrees to provide information for me.

I am between 13 and 17 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NRCT-101SR with low dose NRCT-202XR or NRCT-101SR placebo with varying doses of NRCT-202XR over a 6-week period

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NRCT-101SR with NRCT-202XR

Trial Overview The study is testing if combining two drugs (NRCT-101SR with NRCT-202XR) is more effective for treating ADHD than using NRCT-202XR alone. Participants will be randomly assigned to either receive both drugs or just one in a double-blind setting where neither they nor the researchers know which group they're in.

Participant Groups

Group I: Arm 1 Active Control 1 Intervention

NRCT-101SR and low dose NRCT-202XR

Group II: Arm 2 Active Control 1 Intervention

NRCT-101SR placebo and high dose NRCT-202XR

Group III: Arm 3 Active Control 1 Intervention

NRCT-101SR placebo and low dose NRCT-202XR

NRCT-101SR with NRCT-202XR is already approved in United States for the following indications:

Approved in United States as NRCT-101SR with NRCT-202XR for:

• Attention Deficit Hyperactivity Disorder (ADHD)

Who Is Running the Clinical Trial?

Neurocentria, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Findings from Research

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 2-year open-label study involving participants aged 6-17 with ADHD, extended-release guanfacine (GXR) demonstrated long-term safety and efficacy, with most adverse events being mild to moderate.

Significant improvements in ADHD symptoms were observed as early as the first month and continued throughout the 24-month treatment period, supporting GXR as a viable monotherapy for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Sallee, FR., Lyne, A., Wigal, T., et al.[2013]

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]

Atomoxetine is a non-stimulant medication that effectively treats ADHD in children, adolescents, and adults, improving not just core symptoms but also social functioning and self-esteem.

It has a favorable safety profile with low abuse potential and can be taken once daily for continuous symptom relief, marking a significant advancement in ADHD treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atomoxetine: a new pharmacotherapeutic approach in the management of attention deficit/hyperactivity disorder. Barton, J.[2018]

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]

Atomoxetine has been evaluated for safety and efficacy in treating ADHD in over 4000 patients across various studies, including randomized controlled trials and longitudinal studies.

Recent large cohort studies indicate that atomoxetine is both effective and well-tolerated for children and adolescents, providing important insights into its long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atomoxetine in the treatment of children and adolescents with attention deficit hyperactivity disorder. Kohn, MR., Tsang, TW., Clarke, SD.[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]

In a safety analysis of 15 clinical trials involving 4829 adults with ADHD, atomoxetine was associated with a higher rate of treatment-emergent adverse events compared to placebo (81.3% vs. 68.3% for acute trials), but no new adverse events were identified, confirming its known safety profile.

Atomoxetine led to modest increases in heart rate and blood pressure, but there was no increased risk of serious adverse events or suicidal ideation, indicating it is a safe treatment option for adults with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials. Camporeale, A., Porsdal, V., De Bruyckere, K., et al.[2015]

Guanfacine extended-release (GXR) demonstrated consistent efficacy in reducing ADHD symptoms across various subgroups, including ADHD-combined and ADHD-predominantly inattentive types, with effect sizes around 0.52 for both subtypes in a study of 200 adults.

The safety profile of GXR was generally similar across subgroups, but females experienced a higher incidence of treatment-emergent adverse events, indicating the need for careful monitoring and dose optimization, especially in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guanfacine extended-release in Japanese adults with attention-deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study. Naya, N., Sakai, C., Okutsu, D., et al.[2021]

Adderall XR is a long-acting psychostimulant approved for treating ADHD in both children and adults, with a 12-hour duration of action and demonstrated superior efficacy compared to the nonstimulant atomoxetine.

The largest effectiveness trial for ADHD therapies confirmed that Adderall XR significantly improves quality of life in children and shows proven safety and efficacy in adults, with potential benefits for treating comorbid conditions like oppositional defiant disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adderall XR: long acting stimulant for single daily dosing. Sallee, FR., Smirnoff, AV.[2019]

References

1. 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]

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

Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. [2013]

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. England pubmed.ncbi.nlm.nih.gov

Atomoxetine: a new pharmacotherapeutic approach in the management of attention deficit/hyperactivity disorder. [2018]

5. 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]

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

Efficacy and safety of atomoxetine in the treatment of children and adolescents with attention deficit hyperactivity disorder. [2021]

7. 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]

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

Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials. [2015]

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

Efficacy and safety of guanfacine extended-release in Japanese adults with attention-deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Adderall XR: long acting stimulant for single daily dosing. [2019]