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Stimulant

CTx-1301 for 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
Subject must be able to swallow the CTx-1301 tablet as evidenced by ability to swallow a similar size tablet at screening
Subject must have a body weight between the 5th and 95th percentile for their respective age and sex
Must not have
Subject has a history of allergic reaction or sensitivity to methylphenidate, dexmethylphenidate, or any other substance contained in CTx-1301 or the placebo drug
Subject has family history of early cardiovascular disease or sudden death
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-dose at day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on day 63.
Awards & highlights
Pivotal Trial

Summary

This trial tests a new drug to help kids (6-12) with ADHD in a lab classroom setting to see if it's safe and effective.

Who is the study for?
This trial is for children aged 6-12 with ADHD who are in good health and meet the DSM-5 criteria for ADHD. They must score above certain thresholds on specific ADHD scales, be able to stop current ADHD medications, understand English, and not have any significant medical conditions or psychiatric disorders that could interfere with the study.
What is being tested?
The trial tests various doses of CTx-1301 (a form of dexmethylphenidate) against a placebo to see how effective and safe it is in treating pediatric ADHD within a controlled classroom setting. The goal is to find an optimal dose that improves attention without causing harm.
What are the potential side effects?
Potential side effects may include typical stimulant-related issues such as trouble sleeping, decreased appetite, stomachaches, headaches, increased blood pressure and heart rate. There might also be mood swings or nervousness similar to other medications used for treating ADHD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills similar in size to the CTx-1301 tablet.
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My weight is within the normal range for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to methylphenidate or similar medications.
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My family has a history of heart disease or sudden death at a young age.
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I have been diagnosed with a sleep disorder.
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My close family member has schizophrenia, schizoaffective, bipolar I, or bipolar II disorder.
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I have a long-term brain or spinal cord condition.
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I have used anticonvulsants within the last 2 years.
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ADHD medications do not work for me or cause severe side effects.
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I have previously been treated with CTx-1301.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-dose at day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on day 63.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-dose at day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on day 63. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline (pre-dose measured at Day 63) of the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-combined scores collected across the 14-hour classroom day.
Secondary study objectives
Measure - CGI-I
Measure - CGI-S
Measure - Laboratory Classroom Onset and Duration
+2 more
Other study objectives
Exploratory Endpoints

Awards & Highlights

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

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: 6.25mg CTx-1301 (Dexmethylphenidate tablet)Experimental Treatment1 Intervention
All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Group II: Experimental: 37.5mg CTx-1301 (Dexmethylphenidate tablet)Experimental Treatment6 Interventions
All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Group III: Experimental: 31.25mg CTx-1301 (Dexmethylphenidate tablet)Experimental Treatment5 Interventions
All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Group IV: Experimental: 25.0mg CTx-1301 (Dexmethylphenidate tablet)Experimental Treatment4 Interventions
All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Group V: Experimental: 18.75mg CTx-1301 (Dexmethylphenidate tablet)Experimental Treatment3 Interventions
All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Group VI: Experimental: 12.5mg CTx-1301 (Dexmethylphenidate tablet)Experimental Treatment2 Interventions
All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Group VII: Placebo Comparator: PlaceboPlacebo Group1 Intervention
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTx-1301 - Dexmethylphenidate 37.5mg
2022
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

Cingulate TherapeuticsLead Sponsor
4 Previous Clinical Trials
196 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
169 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Matt Brams, MDStudy DirectorCingulate
3 Previous Clinical Trials
175 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
148 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

CTx-1301 (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05924594 — Phase 3
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Experimental: 6.25mg CTx-1301 (Dexmethylphenidate tablet), Experimental: 31.25mg CTx-1301 (Dexmethylphenidate tablet), Experimental: 12.5mg CTx-1301 (Dexmethylphenidate tablet), Experimental: 25.0mg CTx-1301 (Dexmethylphenidate tablet), Experimental: 18.75mg CTx-1301 (Dexmethylphenidate tablet), Experimental: 37.5mg CTx-1301 (Dexmethylphenidate tablet), Placebo Comparator: Placebo
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: CTx-1301 Highlights & Side Effects. Trial Name: NCT05924594 — Phase 3
CTx-1301 (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924594 — Phase 3
~26 spots leftby Aug 2026
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