NRCT-101SR + NRCT-202XR for ADHD
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Neurocentria, Inc.
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
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.
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.
36789What 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.
124510Will 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.
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 am between 13 and 17 years old.
Participant Groups
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.
3Treatment groups
Active Control
Group I: Arm 1Active Control1 Intervention
NRCT-101SR and low dose NRCT-202XR
Group II: Arm 2Active Control1 Intervention
NRCT-101SR placebo and high dose NRCT-202XR
Group III: Arm 3Active Control1 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)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Accel Research Site-Maitland Clinical Research UnitMaitland, FL
iRresearch AtlantaDecatur, GA
Boston Clinical Trials LLCBoston, MA
Center For Psychiatry and Behavioral MedicineLas Vegas, NV
More Trial Locations
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Who is running the clinical trial?
Neurocentria, Inc.Lead Sponsor
References
Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study. [2022]Atomoxetine is an investigational, nonstimulant pharmacotherapy being studied as potential treatment for attention-deficit/hyperactivity disorder (ADHD). It is thought to act via blockade of the presynaptic norepinephrine transporter in the brain. We assessed the efficacy of 3 doses of atomoxetine compared with placebo in children and adolescents with ADHD.
Atomoxetine: a new pharmacotherapeutic approach in the management of attention deficit/hyperactivity disorder. [2018]Atomoxetine is a novel, non-stimulant, highly selective noradrenaline reuptake inhibitor that has been studied for use in the treatment of attention deficit/hyperactivity disorder (ADHD). Data from clinical trials show it to be well tolerated and effective in the treatment of ADHD in children, adolescents, and adults. Improvements were seen not only in core symptoms of ADHD, but also in broader social and family functioning and self esteem. Once-daily dosing of atomoxetine has been shown to be effective in providing continuous symptom relief. Atomoxetine does not appear to have abuse potential and is associated with a benign side effect profile. The development of atomoxetine thus represents an important advance in the pharmacological management of ADHD.
Adderall XR: long acting stimulant for single daily dosing. [2019]Adderall XR (SLI381) is the latest addition to the group of psychostimulant formulations, which provides the mixed amphetamine salts contained in Adderall as a single-daily dose formulation. Adderall XR is indicated for the treatment of attention deficit hyperactivity disorder in children and adolescents, with recent US Food and Drug Administration approval for attention deficit hyperactivity disorder in adults. Novel and important aspects of Adderall XR is its 12 h duration of action, relative superior efficacy to nonstimulant atomoxetine in a comparator trial, and significant quality of life impact in children, confirmed by the largest effectiveness trial yet to be performed for any attention deficit hyperactivity disorder therapy. Potentially important benefits of Adderall XR are proven safety and efficacy in adults with attention deficit hyperactivity disorder and positive postmarketing findings in treating oppositional defiant disorder -- the most common comorbidity in children with attention deficit hyperactivity disorder. This review summarizes the important properties of Adderall XR, to include a distinct two-stage delivery system and combination of active ingredients, offering unique advantages. Relevant clinical trials and the newest data from meeting reports are also discussed.
Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. [2013]Short-term, controlled studies of extended-release guanfacine (GXR), a selective alpha(2A)-adrenoreceptor agonist, demonstrate efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms as monotherapy. This 2-year open-label study was conducted to further assess the long-term safety and efficacy of GXR.
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.
Efficacy and safety of atomoxetine in the treatment of children and adolescents with attention deficit hyperactivity disorder. [2021]Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication.
Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials. [2015]The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In total, 4829 adults (18-77 years, median: 36 years) were exposed to atomoxetine. Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81.3% vs. 68.3% acute; 90.6% vs. 76.8% long term) and discontinued due to adverse events (8.9% vs. 4.0% acute; 17.9% vs. 6.3% long term). No statistically significant differences were observed in the proportion of patients experiencing serious adverse events. No previously unknown adverse events were identified. The most common adverse events included nausea, dry mouth, decreased appetite, insomnia and erectile dysfunction. Mean increases in heart rate (+5.2 beats per min) and blood pressure (systolic +2 mmHg, diastolic +1.9 mmHg) were modest. The proportion of patients experiencing clinically significant increases in blood pressure and heart rate at any time was statistically significantly higher with atomoxetine (systolic blood pressure 13-17%, diastolic blood pressure 37-40%, heart rate 42-43%) compared to placebo (systolic blood pressure 8-13%, diastolic blood pressure 29-34%, heart rate 21-26%). There was no increased risk of suicidal ideation or behaviour. Our findings confirm atomoxetine's known safety profile. From a safety perspective, atomoxetine is a useful treatment option for adults with attention deficit hyperactivity disorder.
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]Previously, we reported on the efficacy and safety of guanfacine extended-release (GXR) in Japanese adults with attention-deficit/hyperactivity disorder (ADHD) from a phase 3, double-blind, placebo-controlled, randomized trial. In this exploratory post hoc analysis, we assessed the efficacy and/or safety of GXR in the following subgroups: ADHD-combined (ADHD-C) and ADHD-predominantly inattentive (ADHD-I) subtypes, age (≥31,
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.
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.