NRCT-101SR for ADHD
(ADHD Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Neurocentria, Inc.
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
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.
What data supports the idea that NRCT-101SR for ADHD is an effective treatment?
The available research does not provide specific data on the effectiveness of NRCT-101SR for ADHD. However, it does mention other treatments like AKL-T01, an app-based treatment, which showed improvement in ADHD symptoms in children. Clonidine was also noted to help children with both ADHD and conduct disorder. Without specific data on NRCT-101SR, we can't compare its effectiveness to these treatments.
12345What safety data exists for NRCT-101SR for ADHD?
The provided research does not specifically mention NRCT-101SR or NRCT-101. However, it discusses the safety of non-stimulant ADHD medications, including atomoxetine, clonidine, and guanfacine, which are associated with adverse events like ineffectiveness, fatigue, somnolence, and suicidal ideation. Clonidine and its extended-release form are reported to be well-tolerated, with side effects such as somnolence, fatigue, headache, bradycardia, and hypotension. There are concerns about serious side effects like sudden cardiac death and suicidality with ADHD medications in general, indicating a need for further study. No specific safety data for NRCT-101SR is available in the provided research.
678910Eligibility Criteria
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
+2 more
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.
+21 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment1 Intervention
Up to 2,000 mg/day
Group II: Control ArmPlacebo Group1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Advanced Research Center, IncAnaheim, CA
Accel Research Sites Network - MaitlandMaitland, FL
Bio-Medical Research LLCMiami, FL
iResearch AtlantaDecatur, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Neurocentria, Inc.Lead Sponsor
References
Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. [2021]STARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8-14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale-Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: -0.7, p
The Use of Brexpiprazole Combined With a Stimulant in Adults With Treatment-Resistant Attention-Deficit/Hyperactivity Disorder. [2022]This is the first controlled pharmacologic study in either adults or children with uncomplicated, treatment-resistant attention-deficit/hyperactivity disorder (ADHD). This study augmented stimulant therapy with the atypical antipsychotic brexpiprazole. The Food and Drug Administration preapproved primary outcome measure (Conners' Adult ADHD Rating Scale [CAARS]) showed no drug-placebo differences. Often studies showing no efficacy on the prestudy, defined primary outcome variable go unpublished. While this is decried, publishing studies with equivocal results remains rare. This reanalysis highlights trends in secondary measures having implications for treatment and research regarding treatment resistant ADHD.
Clonidine therapy for comorbid attention deficit hyperactivity disorder and conduct disorder: preliminary findings in a children's inpatient unit. [2019]This retrospective study examined the clinical course of 18 prepubertal boys (aged 6 to 12) who had dual diagnoses of attention deficit hyperactivity disorder and conduct disorder and who received clonidine on an inpatient basis after failed trials of conventional drug therapy, consisting predominantly of psychostimulants. The effects of clonidine were assessed during inpatient treatment and after discharge at intervals of 1 to 2 months. Eleven (61%) of the children had marked improvement as measured by clinical impression. Transient sedation lasting 2 to 3 days occurred after initial administration or dosage increase; otherwise, clonidine was well tolerated. Our findings suggest that clonidine may prove to be an alternative treatment of comorbid attention deficit hyperactivity disorder and conduct disorder.
Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. [2021]The relatively short durations of the initial pivotal randomized placebo-controlled trials involving atomoxetine HCl for the treatment of attention-deficit/hyperactivity disorder (ADHD) provided limited insight into the time courses of ADHD core symptom responses to this nonstimulant, selective norepinephrine reuptake inhibitor. The aim of this analysis was to evaluate time courses of treatment responses or remission, as assessed by attainment of prespecified scores on the ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) and the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) scales, during up to 1 year of atomoxetine treatment in children with ADHD.
Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD. [2020]Neurofeedback (NF) has gained increasing interest among non-pharmacological treatments for Attention Deficit Hyperactivity Disorder (ADHD). NF training aims to enhance self-regulation of brain activities. The goal of the NEWROFEED study is to assess the efficacy of a new personalized NF training device, using two different protocols according to each child's electroencephalographic pattern, and designed for use at home. This study is a non-inferiority trial comparing NF to methylphenidate.
Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. [2021]Attention deficit hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders in children and although stimulant medications remain first line to treat the disorder, some families prefer nonstimulants. The goal is to analyze the adverse events (AE) associated with nonstimulant medications using post-marketing drug surveillance data. We aim to increase awareness and aide patient education. A retrospective study of adverse drug events with atomoxetine, clonidine, and guanfacine was performed using the Federal Drug Administration Adverse Event Reporting System (FAERS) Database. Results show that the most commonly reported AEs, as defined by FAERS, were ineffectiveness (9.91-14.15%) fatigue (8.93%), and somnolence (8.8-10.16%). Of those taking atomoxetine, suicidal and self-injurious ideation was reported to a similar degree amongst all age groups. Suicidal ideation was listed within the top 20 most reported AEs for all three medications. It is more likely that some patients will experience milder side effects. We suggest providing these data to patients to help overcome the stigma of starting medication, especially if they prefer nonstimulants. Serious AEs are still reported to a small degree, thus monitoring and consistent patient education remains important. We also recommend educating a wider demographic of patients about recognizing potential development of suicidal thoughts.
Use of serotonin norepinephrine reuptake inhibitors in the treatment of attention-deficit hyperactivity disorder in pediatrics. [2022]To review the current literature on the efficacy and safety of serotonin norepinephrine reuptake inhibitors in the treatment of attention-deficit hyperactivity disorder (ADHD) in the pediatric population.
Safety and efficacy of clonidine and clonidine extended-release in the treatment of children and adolescents with attention deficit and hyperactivity disorders. [2021]Clonidine has been used off-label in children and adolescents with attention deficit and hyperactivity disorders (ADHD) with or without comorbidities. Clonidine extended-release was recently approved by the US Food and Drug Administration for ADHD in children. This review evaluates the efficacy and safety of clonidine extended-release and clonidine in children and adolescents with ADHD. A search of the Medline database and clinical trials register from 1996-2011 yielded ten clinical trials for critical evaluation of efficacy and safety. Eight of the ten trials reviewed were double-blinded and placebo-controlled. Nine of the ten trials utilized multiple outcome measures. Both clonidine extended-release and clonidine, as monotherapy or adjunctive therapy, were reported to be efficacious in treating ADHD symptoms in children and adolescents with or without comorbid disorders in nine of the ten clinical trials. One study showed clonidine to be ineffective in improving performance of a single task, at a specific point in time, in a small number of subjects. All of the studies that evaluated safety reported clonidine and clonidine extended-release to be well tolerated. The side effects of clonidine included somnolence, fatigue, headache, bradycardia, hypotension, and clinically insignificant electrocardiographic changes. However, there are historical anecdotal reports of serious cardiac side effects, including death in cases with other risk factors. None of the studies compared clonidine extended-release with clonidine in subjects with ADHD. Therefore, it is not clear whether clonidine extended-release is advantageous over clonidine, with regard to either efficacy or safety. It is equally unclear whether clonidine or clonidine extended-release is more efficacious in treating ADHD in subjects with comorbid disorders than in those without comorbidities. All the studies reviewed had limitations in their designs and methods. Clonidine and clonidine extended-release could be efficacious and safe for the treatment of ADHD both as monotherapy and as adjunctive therapy with stimulant medications in selected patients. There is a need for clinical trials to determine the long-term efficacy and safety of treatment with clonidine and clonidine extended-release in patients with ADHD.
European guidelines on managing adverse effects of medication for ADHD. [2022]The safety of ADHD medications is not fully known. Concerns have arisen about both a lack of contemporary-standard information about medications first licensed several decades ago, and signals of possible harm arising from more recently developed medications. These relate to both relatively minor adverse effects and extremely serious issues such as sudden cardiac death and suicidality. A guidelines group of the European Network for Hyperkinetic Disorders (EUNETHYDIS) has therefore reviewed the literature, recruited renowned clinical subspecialists and consulted as a group to examine these concerns. Some of the effects examined appeared to be minimal in impact or difficult to distinguish from risk to untreated populations. However, several areas require further study to allow a more precise understanding of these risks.
Updates in Pharmacologic Strategies in Adult Attention-Deficit/Hyperactivity Disorder. [2022]Attention-deficit/hyperactivity disorder (ADHD) significantly worsens quality of life and long-term functional outcomes in adults. Individual impairments in adults with ADHD can be further contextualized within considerable costs to society at large. Food and Drug Administration (FDA) approved stimulants and nonstimulant medications can significantly improve ADHD symptoms in adults. In the past 2 decades, the United States FDA has expanded approval of pharmacotherapeutic options for adult ADHD. However, limitations still persist in available psychotropics for certain patient populations such as those with comorbid substance use or cardiovascular illness. Clinicians therefore must appreciate several ongoing investigations into medications with unique mechanisms of action. This article reviews the current FDA approved and emerging medication options while providing guidelines for pharmacologic management of adult ADHD.
A randomized, double-blind, placebo-controlled phase 2 study of α4β2 agonist ABT-894 in adults with ADHD. [2021]Dysregulation of the neuronal nicotinic acetylcholine receptor (NNR) system has been implicated in attention-deficit/hyperactivity disorder (ADHD), and nicotinic agonists improve attention across preclinical species and humans. Hence, a randomized, double-blind, placebo-controlled, crossover study was designed to determine the safety and efficacy of a novel α4β2 NNR agonist (ABT-894 (3-(5,6-dichloro-pyridin-3-yl)-1(S),5 (S)-3,6-diazabicyclo[3.2.0]heptane)) in adults with ADHD. Participants (N=243) were randomized to one of four dose regimens of ABT-894 (1, 2, and 4 mg once daily (QD)) or 4 mg twice daily (BID) or the active comparator atomoxetine (40 mg BID) vs placebo for 28 days. Following a 2-week washout period, participants crossed over to the alternative treatment condition (active or placebo) for an additional 28 days. Primary efficacy was based on an investigator-rated Conners' Adult ADHD Rating Scale (CAARS:Inv) Total score at the end of each 4-week treatment period. Additional secondary outcome measures were assessed. A total of 238 patients were assessed for safety end points, 236 patients were included in the intent-to-treat data set, and 196 were included in the completers data set, which was the prespecified, primary data set for efficacy. Both the 4 mg BID ABT-894 and atomoxetine groups demonstrated significant improvement on the primary outcome compared with placebo. Several secondary outcome measures were also significantly improved with 4 mg BID ABT-894. Overall, ABT-894 was well tolerated at all dose levels. These results provide initial proof of concept for the use of α4β2 agonists in the treatment of adults with ADHD. Further investigation of ABT-894, including higher doses, is therefore warranted.
Atomoxetine for attention deficit hyperactivity disorder in mental retardation. [2015]The study objective was to assess the efficacy and tolerability of atomoxetine in the treatment of attention deficit hyperactivity disorder symptoms in patients with mental retardation. In a 16-week, open-label, prospective study, 48 children with mental retardation and attention deficit hyperactivity disorder were recruited; the patients received atomoxetine, with a single final dose of 1.2 mg/kg per day reached at 3 weeks. The measure of efficacy was scores on Clinical Global Impression Severity scale (CGI-S), Conners, and Attention Deficit Hyperactivity Disorder Rating Scale ADHDRS-IV. A statistically significant difference was documented between the mean CGI-S scores before and after treatment: baseline CGI-S = 5.31 (S.D. = 0.85); post-treatment CGI-S = 4.13 (S.D. = 0.97), with a difference of 1.18 points (S.D. = 0.84) and a 95% confidence interval for the difference of 0.92-1.43 (P
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. [2013]ABT-089, an α4β2 neuronal nicotinic receptor partial agonist (generic name pozanicline), has demonstrated efficacy in adults with attention-deficit/hyperactivity disorder (ADHD) at doses of 40 mg once daily and 40 mg twice daily. The purpose of this exploratory pilot study was to obtain initial safety, tolerability, and efficacy data for an ABT-089 80-mg once-daily regimen to inform a decision of whether to include an 80-mg once-daily dose regimen in subsequent, definitive (phase 3) efficacy studies.
[Atomoxetine: a new treatment for Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescents]. [2020]This paper provides a review of safety and efficacy data as well as of pharmacological characteristics of atomoxetine, a new drug treatment for the Attention Deficit/Hyperactivity Disorder (ADHD). To date, the only pharmacological treatment available in France for children and adolescents diagnosed with ADHD is methylphenidate, a psychostimulant drug. However, the clinical response to methylphenidate may be absent or insufficient in about 20-30% drug-treated children while the occurrence of adverse effects with methylphenidate (sleep disturbances, loss of appetite, tics increase...) may sometimes require a dose reduction or even the discontinuation of the treatment. Atomoxetine is an alternative candidate drug for the treatment of ADHD. The drug has been developed with respect to the actual standards of investigation of drugs intended to a -pediatric use. Atomoxetine has been recently licensed in the USA for the treatment of ADHD. Atomoxetine is a potent inhibitor of the norepinephrine transporter that shows only mini-mal affinity for other neurotransmitter systems. Although pharmacokinetics of atomoxetine is influenced by the polymorphism of the CYP2D6 metabolic pathway, safety and -tolerability data reported during clinical trials did not show any difference in poor versus extensive metabolizers. In addition, atomoxetine does not inhibit nor induce the CYP2D6 enzymatic function. The major metabolite of atomoxetine is 4-hydroxyatomoxetine, a pharmacologically active metabolic found in very low plasma concentrations in pediatric patients, suggesting that it plays only a minor role in the norepinephrine reuptake inhibition. Preliminary studies were aimed to assess the effective dose range of atomoxetine and to evaluate its safety and efficacy on the reduction of ADHD symptoms in adults and children diagnosed with ADHD. Main data on the child and adolescent population were obtained in four double-blind, randomized, placebo-controlled trials: two identical pivotal trials, a multiple dose study, a once-daily dose study. The first two pivotal trials were carried out in ADHD children aged 7-13 years, treated with atomoxetine vs placebo for a duration of 9 weeks. Patients presenting comorbidities (ie conduct disorder, -anxiety, depression) as well as a history of previous treatment with methylphenidate were also eligible to participate. The primary outcome was the reduction of the score on the ADHD rating scale, ADHD-RS ; secondary criteria included the responder's rate (patients with an ADHD-RS score reduction of 25% or above), the Clinical Global Impression Scale and the Conners Parent Rating Scale. With a mean dose of 1.5 mg/kg/day, atomoxetine showed a significant reduction of mean ADHD-RS scores at endpoint (ANOVA, p
Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. [2021]To assess the safety and efficacy of ABT-089, a novel α(4)β(2) neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD).