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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can swallow pills similar in size to the CTx-1301 tablet.
Select...
My weight is within the normal range for my age and sex.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Measure - CGI-I
Measure - CGI-S
Measure - Laboratory Classroom Onset and Duration
+2 moreOther outcome measures
Exploratory Endpoints
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
192 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
165 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Matt Brams, MDStudy DirectorCingulate
3 Previous Clinical Trials
171 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
144 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to methylphenidate or similar medications.You need to score 28 or higher on the ADHD-RS-5 scale during the screening and baseline visits.I am not pregnant or breastfeeding and won't be for 30 days after the study ends.I can swallow pills similar in size to the CTx-1301 tablet.Your thyroid disorder is not well controlled, as indicated by specific levels of thyroid stimulating hormone (TSH) in your blood.My family has a history of heart disease or sudden death at a young age.I am in good overall health.You have ever tried to harm yourself or seriously thought about doing so.You must meet the criteria for ADHD in the DSM-5.I have been diagnosed with a sleep disorder.I am not happy with my current ADHD medication or I am not taking any.My close family member has schizophrenia, schizoaffective, bipolar I, or bipolar II disorder.I have a long-term brain or spinal cord condition.You must have a score of 4 or higher on a scale used by the doctor to measure how severe your condition is.I have used anticonvulsants within the last 2 years.If your blood pressure is higher than what is considered normal for someone your age, you cannot participate.ADHD medications do not work for me or cause severe side effects.I am willing to stop taking my ADHD medications for the study.I do not have any major health issues that could affect my participation in the study.You have a history of drug or alcohol abuse, or test positive for drugs during the study.My intellectual abilities are appropriate for my age.I am between 6 and 12 years old.My weight is within the normal range for my age and sex.I have previously been treated with CTx-1301.Women who could become pregnant must have a negative pregnancy test before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: 6.25mg CTx-1301 (Dexmethylphenidate tablet)
- Group 2: Experimental: 12.5mg CTx-1301 (Dexmethylphenidate tablet)
- Group 3: Experimental: 31.25mg CTx-1301 (Dexmethylphenidate tablet)
- Group 4: Experimental: 18.75mg CTx-1301 (Dexmethylphenidate tablet)
- Group 5: Experimental: 25.0mg CTx-1301 (Dexmethylphenidate tablet)
- Group 6: Experimental: 37.5mg CTx-1301 (Dexmethylphenidate tablet)
- Group 7: Placebo Comparator: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation permit elderly individuals to participate?
"The data associated with this medical trial indicates that the target population is 6 to 12 year-olds. For those younger than 18 there are 118 trials and for individuals over 65, 36 studies exist."
Answered by AI
Could I be considered as a potential participant in this investigation?
"Patients that meet the criteria of having Attention Deficit Hyperactivity Disorder (ADHD) and are 6 to 12 years old can qualify for this research trial. 82 recruits will be accepted in total."
Answered by AI
Are there any opportunities to participate in this clinical experiment currently available?
"According to clinicaltrials.gov, this trial has since closed its recruitment period on June 28th 2023; it was first published July 1st 2022. Despite the completion of their patient search, 168 other trials are still actively recruiting participants at the present moment."
Answered by AI
Has the 6.25mg CTx-1301 (Dexmethylphenidate tablet) been authorized by the FDA?
"The safety of Experimental: 6.25mg CTx-1301 (Dexmethylphenidate tablet) was rated 3 on our scale at Power, since the Phase 3 trial had collected ample evidence for both efficacy and security."
Answered by AI
Who else is applying?
What site did they apply to?
Center for Psychiatry & Behavioral Medicine
What portion of applicants met pre-screening criteria?
Met criteria
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