What side effects are associated with this type of intervention?

Common treatments for ADHD, such as stimulant medications like methylphenidate (including d-MPH) and amphetamines, are associated with several side effects. These can include increased heart rate and blood pressure, sleep disturbances such as insomnia, decreased appetite, weight loss, and potential for increased anxiety or irritability. Cardiovascular effects are generally modest but should be monitored, especially in patients with pre-existing heart conditions. Additionally, some individuals may experience gastrointestinal issues, headaches, or dizziness. It is important to tailor the treatment to the individual and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved several stimulant medications for the treatment of ADHD, which work by increasing dopamine and norepinephrine levels in the brain. These include methylphenidate (MPH) and its various formulations, such as immediate-release, extended-release, and enantiomer-specific versions like d-MPH. Mixed amphetamine salts, including Adderall and its extended-release form, are also commonly used. Additionally, non-stimulant options like atomoxetine and alpha-2-adrenergic agonists (e.g., guanfacine) are available for patients who do not respond well to stimulants or have contraindications.

What other types of research exist?

Promising novel alternatives to CTx-1301 for ADHD treatment include Serdexmethylphenidate (SDX/d-MPH), which has shown significant improvement in ADHD symptoms with a rapid onset and extended duration of effect. Additionally, extended-release guanfacine has been effective in managing ADHD symptoms, particularly in children and adolescents. Both options have demonstrated safety profiles comparable to other stimulant treatments.

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Central Nervous System Stimulant

CTx-1301 for Pediatric ADHD

Phase 3

Waitlist Available

Research Sponsored by Cingulate Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening to visit 9 (approximately 6-10 weeks, depending on screening window)

Awards & highlights

Pivotal Trial

Summary

This trial tests CTx-1301, a medication for children and teens with moderate to severe ADHD. The drug aims to balance brain chemicals to improve focus and reduce impulsive actions.

Who is the study for?

This trial is for boys and girls aged 6-17 with ADHD who are in good health, have an age-appropriate intellectual function, and score at least 28 on the ADHD-RS-5 scale. They must not be satisfied with current ADHD treatment or may be untreated. Participants need to agree to stop other ADHD medications before starting the study and use birth control if applicable.

What is being tested?

The study tests different fixed doses of a medication called CTx-1301 (d-MPH) against a placebo in children with ADHD. It's randomized, meaning participants are put into groups by chance, double-blind so neither researchers nor participants know who gets what treatment, and placebo-controlled to compare results against no active treatment.

What are the potential side effects?

Possible side effects of CTx-1301 include sleep problems, decreased appetite, stomach pain, nausea, anxiety/nervousness; however specific side effects will be monitored throughout the trial as it involves children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening to visit 9 (approximately 6-10 weeks, depending on screening window)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening to visit 9 (approximately 6-10 weeks, depending on screening window)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to visit 9 (approximately 6-10 weeks, depending on screening window) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary efficacy analysis will analyze the mean change from Baseline (pre-dose) at Visit 2 of Attention Deficit Hyperactivity Disorder Rating Scale 5 (ADHD-RS-5) scores to ADHD-RS-5 at Visit 8.

Secondary study objectives

The primary efficacy analysis will analyze the mean change from Baseline (pre-dose) at Visit 2 of Clinical Global Impression - Severity (CGI-S) scores to CGI-S at Visit 8.

Other study objectives

Population PK Analysis - AUC to Infinity

Population PK Analysis - Cmax

Population PK Analysis - Tmax

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: 18.75 mg CTx-1301 (dexmethylphenidate tablet)Active Control2 Interventions

Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.

Group II: 25 mg CTx-1301 (dexmethylphenidate tablet)Active Control3 Interventions

Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.

Group III: 37.5 mg CTx-1301 (dexmethylphenidate tablet)Active Control4 Interventions

Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.

Group IV: PlaceboPlacebo Group1 Intervention

Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stimulant medications, such as dexmethylphenidate (d-MPH), commonly used to treat ADHD, work by increasing the levels of dopamine and norepinephrine in the brain. These neurotransmitters are crucial for regulating attention, focus, and impulse control. For ADHD patients, this mechanism of action is significant because it directly addresses the core symptoms of the disorder—improving attention span, reducing hyperactivity, and controlling impulsive behaviors. By enhancing neurotransmitter activity, these medications help mitigate the deficits in brain function associated with ADHD.