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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
Study Summary
This trial will study the efficacy and safety of a drug to treat ADHD in children and teens aged 6-17.
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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
Population PK Analysis - AUC to Infinity
Population PK Analysis - Cmax
Population PK Analysis - Tmax
+7 moreTrial 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.
Find a Location
Who is running the clinical trial?
Cingulate TherapeuticsLead Sponsor
4 Previous Clinical Trials
175 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
148 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
69,260 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
460 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Matt Brams, MDStudy DirectorCingulate
3 Previous Clinical Trials
154 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
127 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If your blood pressure is higher than most people your age, sex, and height, it will be measured three times, and if the average of those three readings is very high, you will not be able to participate in the study.You have a history of using drugs or show evidence of drug use. If you have a positive drug test from prescribed medication, you may still be able to join the study if you stop taking the medication as required by the study rules.You have tried to hurt yourself or have had serious thoughts about hurting yourself, as determined by a specific assessment.Your parent or sibling has been diagnosed with schizophrenia, schizoaffective disorder, bipolar I disorder, or bipolar II disorder.You need to have a score of 28 or higher on the ADHD-RS-5 scale during the first visit.You have close family members who had heart problems at a young age or died suddenly due to heart issues.You have taken anticonvulsant medication in the last 2 years.Your thyroid levels are not within the normal range.You have been treated with CTx-1301 before.You have been diagnosed with mental health conditions like bipolar disorder, major depression, or anxiety disorder, as well as other behavioral or cognitive disorders.You have a long-term illness affecting your brain or nervous system, such as tumors, inflammation, seizures, or a serious head injury.You have already tried ADHD medication and it didn't work for you, or you couldn't tolerate it.You are not happy with your current medication for ADHD, or you are not taking any medication for ADHD. If you have never taken medication for ADHD before, you can still participate.Your body weight must be within the normal range for your age and gender.If you are a girl who has started having periods or are 12 years old or older, or if you are a woman capable of having children, you must agree to use effective birth control during the study and for some time after finishing the study drug. If you are a boy with a female partner, you must also agree to use birth control during the study and for some time after finishing the study drug.You have a diagnosed sleep disorder, like sleep apnea or narcolepsy.You must be moderately ill according to the clinician's assessment at the start of the study.You have a history of seizures, except for those caused by fever.You are not happy with your current medication for ADHD or you are not taking any medication for ADHD.You must be diagnosed with ADHD according to specific guidelines and confirmed by a special interview for children and teenagers. This interview will also check for other mental health issues.
Research Study Groups:
This trial has the following groups:- Group 1: 18.75 mg CTx-1301 (dexmethylphenidate tablet)
- Group 2: 25 mg CTx-1301 (dexmethylphenidate tablet)
- Group 3: 37.5 mg CTx-1301 (dexmethylphenidate tablet)
- Group 4: 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.
Are geriatric patients precluded from this research project?
"The official prerequisites for this medical trial are that the minimum age of participants is 6, and the maximum allowed age is 17."
Answered by AI
To what degree is this medical research being conducted in the United States?
"Meridien Research in Maitland, Georgia, Atlanta Center for Medical Research in Orlando, Massachusetts and Sisu Bhr Llc in Atlanta Michigan are just some of the 24 sites administering this clinical trial."
Answered by AI
What is the eligibility criteria for joining this clinical trial?
"This clinical trial is enrolling 385 individuals between the ages of 6 and 17 who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) as a qualifying factor."
Answered by AI
What are the potential adverse effects of administering 18.75 mg CTx-1301 (dexmethylphenidate tablet) to patients?
"Our team at Power determined that 18.75 mg CTx-1301 (dexmethylphenidate tablet) is likely safe, scoring a 3 out of 3 due to the multiple rounds of data supporting efficacy and safety from its Phase 3 clinical trial."
Answered by AI
Is this research project recruiting participants at the moment?
"Per the information found on clinicaltrials.gov, this investigation is no longer seeking participants. First posted in July 1st 2023 and last edited June 21st of the same year, unfortunately there are not any open slots available for enrolment at this time; however 1102 other studies have vacancies presently."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
What site did they apply to?
Center for Psychiatry and Behavioral Medicine. Inc.
Summit Research Network, LLC
Access Clinical Trials Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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