ADHDPhase 3NCT05631626
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
A Phase 3 study testing CTx-1301 - Dexmethylphenidate 25mg, CTx-1301 - Dexmethylphenidate 37.5mg and CTx-1301 - Dexmethylphenidate 50mg in people with ADHD and ADHD - Combined Type, run by Cingulate Therapeutics at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined
- What is being tested?
- CTx-1301 - Dexmethylphenidate 25mg, CTx-1301 - Dexmethylphenidate 37.5mg and CTx-1301 - Dexmethylphenidate 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2022to 13 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent.
- Subject must have a body mass index (BMI) ≥18.5 and ≤40.
- Subject is unsatisfied with his/her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who are naïve to pharmacological therapy for ADHD is permitted.
- Negative serum beta-human chorionic gonadotropin (hCG) pregnancy test for subjects of child-bearing potential and must agree to remain abstinent or agree to use a highly effective, medically acceptable form of birth control for the time of written or verbal consent and for at least 30 days after the last dose of study drug has been taken (females) unless post-menopausal or surgically sterile. Male subjects with female partners must agree at Screening to remain abstinent or agree to use an effective and medically acceptable form of birth control from Screening to 90 days after the last dose of study drug.
- Subject must be in general good health defined as absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and laboratory values (hematology, chemistry, or urinalysis) at Screening. If any of the exams or values are not within the laboratory reference range, the Investigator must review range and determine if clinically relevant. If clinically relevant, the subject is not eligible for the study.
- Subject's intellectual function is at an appropriate level, as deemed by the Investigator.
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- Subjects need to be able to perform at least the basic level of problems on the PERMP pre-test with at least 10 questions answered correctly per page or 2 minutes performed at Visit 2.
- Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for the primary diagnosis of ADHD for any of the three presentations (combined, inattentive, or hyperactive/impulsive presentation) upon clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Attention Deficit/Hyperactivity Disorder - Adults (MINI).
- Subject must score 24 or higher on the Adult ADHD Investigator Rating Scale (AISRS) at the Screening visit (Visit 1) and Baseline visit (Visit 2) if no ADHD medication washout is required. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout at the Baseline visit (Visit 2).
- Subject must have a score of 4 (moderately ill) or higher on the clinician-administrated Clinical Global Impressions-Severity (CGI-S) scale at Screening. For subjects requiring washout of ADHD medications, this criterion refers to a score at the Baseline visit (Visit 2).
- Subject must be able and willing to wash out of all stimulant ADHD medications (except study drug as indicated per protocol), including herbal medication, from 5 days prior to the start of the dose-optimization phase and for the duration of the entire study, defined as completion of the safety follow-up visit. Additionally, subject must be able and willing to wash out from all non-stimulant ADHD medications 21 days prior to the start of the dose optimization phase and for the duration of the entire study, defined as completion of the safety follow-up visit.
- Subject must be able to read, write, speak, and understand English and be able to communicate with the Investigator and study coordinator in a satisfactory fashion and complete any study-related materials. Subject must plan to be available for the entire duration of the study.
Who cannot join
- If female and of child-bearing potential, the subject must not be pregnant or breastfeeding at any time during the study or for 30 days following the completion of the study. If of child-bearing potential, urine hCG tests will be administered at protocol specified time points. Any positive pregnancy test during the study will exclude them from further participation in the study.
- Subject has any psychiatric diagnosis of bipolar I or II disorder, current major depressive disorder, conduct disorder, disruptive mood dysregulation disorder, intellectual disability, obsessive-compulsive disorder, eating disorder, anxiety disorder (including generalized anxiety disorder), any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances, or any other diagnosis/significant medical history that at the discretion of the Investigator excludes the subject from entry into the study.
- Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS-related disorders that might occur in childhood, or history of persistent neurological symptoms related to a serious head injury.
- Subject has any clinically significant and/or unstable medical abnormality, chronic medical condition, persistent neurological symptoms, history of cardiovascular abnormality, abnormalities of respiratory, hepatic, gastrointestinal, renal, or any disorder or history of a condition that would impact or interfere with drug absorption, distribution, metabolism, or excretion during the study or may interfere with the participants ability to participate in the study.
- Subject has family history of early cardiovascular disease or sudden death.
- Subject has any history of attempted suicide or clinically significant suicidal ideation based on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment, or answers "yes" to "Suicidal Ideation" item 4 or 5 in the past 3 years on the C-SSRS lifetime/recent assessment at Screening.
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- Subject has history of seizures, excluding febrile seizures.
- Subject has a known primary sleep disorder (e.g., sleep apnea, narcolepsy, etc.)
- Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure greater than140 millimeters of mercury (mmHg) or diastolic blood pressure greater than 90 mmHg.
- Subject is considered treatment refractory by the Investigator.
- Any use of anticonvulsants currently or within the past 2 years.
- Uncontrolled thyroid disorder indicated by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥ 1.25 x the upper limit of normal (ULN) from the reference laboratory.
- Subject has first-degree relatives (biological parent or sibling) with a history of schizophrenia, schizoaffective disorder, bipolar I disorder, or bipolar II disorder.
- Subject has history of substance abuse or shows evidence of substance or alcohol use disorder or has a positive urine alcohol or drug screen at Screening. Subjects with positive drug screens may be allowed to continue in the study if the result of the positive drug screen is from prescribed medications and the subject is willing to washout of the medication as required per protocol.
- Subject has a history of physical, emotional, or sexual abuse resulting in a current diagnosis of posttraumatic stress disorder.
- Previous treatment experience/exposure to CTx-1301.
- Subject has a history of allergic reaction or sensitivity to methylphenidate, or any substance contained in CTx-1301 or the placebo drug.
- Subject has participated in a laboratory study within 6 months prior to the start of Screening or has participated in any other clinical study with an investigational drug/product within 90 days prior to Screening or is currently participating in another clinical study.
- Subject anticipates a move outside the geographic range of the investigative site during the duration of the study period or plans on travel that would not allow compliance to the protocol during the study period.
- Subject is unsuitable in any other way to participate in the study, as determined by the Investigator.
- Subjects who are family members of the employees at the study center, of the investigator, or those with direct involvement in the proposed study under the direction of that investigator or study center.
- Subjects that live in the same household are not allowed to be in the same cohort.
- Eligibility Criteria:
- Subjects will be required to meet the following criteria at the end of the dose-optimization phase in order to be eligible for the double-blind, randomized treatment phase. These criteria are based on the efficacy and safety observed over the 5-week dose-optimization period.
- A minimum of 2 sequential weeks on optimal dose.
- A reduction of ≥ 30% of the AISRS from Visit 2 to Visit 7 during the dose optimization phase.
- A CGI-I score of 1 or 2 points ("Very Much Improved" or "Much Improved") at the end of the dose optimization phase.
- Acceptable tolerability of the optimized CTx-1301 dose during the dose optimization phase.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada, 89128
About this study
Official title: A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting.
Read the detailed description
A single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety laboratory classroom study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering a 5-week dose-optimization phase. During the dose-optimization phase subjects will have weekly visit and will be titrated to doses ranging between 25mg-50mg of CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice Adult Laboratory Classroom (ALC) visit with 4 PERMP assessments. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th day subjects will complete a full ALC visit. The duration of the full ALC visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full adult laboratory classroom visit.
- Conditions
- ADHD, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined, Attention Deficit Hyperactivity Disorder
- Being tested
- CTx-1301 - Dexmethylphenidate 25mg, CTx-1301 - Dexmethylphenidate 37.5mg, CTx-1301 - Dexmethylphenidate 50mg, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTx-1301 - Dexmethylphenidate 25mgDrug
Also called All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.
25mg CTx-1301 (Dexmethylphenidate tablet)
CTx-1301 - Dexmethylphenidate 37.5mgDrug
Also called All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.
37.5mg CTx-1301 (Dexmethylphenidate tablet)
CTx-1301 - Dexmethylphenidate 50mgDrug
Also called All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.
50mg CTx-1301 (Dexmethylphenidate tablet)
PlaceboDrug
Also called Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomized phase.
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 25mg CTx-1301 (Dexmethylphenidate tablet) | Active comparator | All subjects will be titrated to their optimal dose during the dose-optimization phase. The starting dose for all subjects at Day 0 is 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. Receives: Drug: CTx-1301 - Dexmethylphenidate 25mg |
| 37.5mg CTx-1301 (Dexmethylphenidate tablet) | Active comparator | All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . 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. Receives: Drug: CTx-1301 - Dexmethylphenidate 37.5mg |
| 50mg CTx-1301 (Dexmethylphenidate tablet) | Active comparator | All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . 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. Receives: Drug: CTx-1301 - Dexmethylphenidate 50mg |
| Placebo | Placebo comparator | Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Analysis Will Analyze the Change in PERMP Scores From Baseline (Pre-dose) at Visit 8 to Hour 16 at Visit 8.
The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Measured: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hour 16 at Visit 8.
Secondary outcomes (2)
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Measured: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hours .5,1,3,6,9,12,13,14,15, and 16.
Key Secondary Analysis Will Analyze the Change From Baseline (Pre-dose at Visit 2) of Clinical Global Impression - Severity (CGI-S) Scores to CGI-S at Visit 8.
The Clinical Global Impression-Severity (CGI-S) scale is a 7-point clinician-rated tool that measures the overall severity of a subject's illness. It rates subjects from 1 (normal) to 7 (among the most extremely ill). A higher score means a worse outcome.
Measured: Baseline (pre-dose at Visit 2) to Visit 8 (approximately 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start29 Dec 2022
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cingulate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc.
- Responsible party
- Sponsor
- Investigators
- Ann Childress, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631626
- Sponsor's protocol ID
- CTx-1301-022
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2022
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
- ClinicalTrials.gov ID
- NCT05631626
- Acronym / sponsor ID
- CTx-1301-022
- Conditions
- ADHD, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined, Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cingulate TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Rho, Inc.
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting.
Detailed description
A single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety laboratory classroom study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering a 5-week dose-optimization phase. During the dose-optimization phase subjects will have weekly visit and will be titrated to doses ranging between 25mg-50mg of CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice Adult Laboratory Classroom (ALC) visit with 4 PERMP assessments. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th day subjects will complete a full ALC visit. The duration of the full ALC visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full adult laboratory classroom visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25mg CTx-1301 (Dexmethylphenidate tablet) | Active comparator | Drug: CTx-1301 - Dexmethylphenidate 25mgAll subjects will be titrated to their optimal dose during the dose-optimization phase. The starting dose for all subjects at Day 0 is 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. |
| 37.5mg CTx-1301 (Dexmethylphenidate tablet) | Active comparator | Drug: CTx-1301 - Dexmethylphenidate 37.5mgAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . 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. |
| 50mg CTx-1301 (Dexmethylphenidate tablet) | Active comparator | Drug: CTx-1301 - Dexmethylphenidate 50mgAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent.
- Subject must have a body mass index (BMI) ≥18.5 and ≤40.
- Subject is unsatisfied with his/her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who are naïve to pharmacological therapy for ADHD is permitted.
- Negative serum beta-human chorionic gonadotropin (hCG) pregnancy test for subjects of child-bearing potential and must agree to remain abstinent or agree to use a highly effective, medically acceptable form of birth control for the time of written or verbal consent and for at least 30 days after the last dose of study drug has been taken (females) unless post-menopausal or surgically sterile. Male subjects with female partners must agree at Screening to remain abstinent or agree to use an effective and medically acceptable form of birth control from Screening to 90 days after the last dose of study drug.
- Subject must be in general good health defined as absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and laboratory values (hematology, chemistry, or urinalysis) at Screening. If any of the exams or values are not within the laboratory reference range, the Investigator must review range and determine if clinically relevant. If clinically relevant, the subject is not eligible for the study.
Key exclusion criteria (28 listed)
- If female and of child-bearing potential, the subject must not be pregnant or breastfeeding at any time during the study or for 30 days following the completion of the study. If of child-bearing potential, urine hCG tests will be administered at protocol specified time points. Any positive pregnancy test during the study will exclude them from further participation in the study.
- Subject has any psychiatric diagnosis of bipolar I or II disorder, current major depressive disorder, conduct disorder, disruptive mood dysregulation disorder, intellectual disability, obsessive-compulsive disorder, eating disorder, anxiety disorder (including generalized anxiety disorder), any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances, or any other diagnosis/significant medical history that at the discretion of the Investigator excludes the subject from entry into the study.
- Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS-related disorders that might occur in childhood, or history of persistent neurological symptoms related to a serious head injury.
- Subject has any clinically significant and/or unstable medical abnormality, chronic medical condition, persistent neurological symptoms, history of cardiovascular abnormality, abnormalities of respiratory, hepatic, gastrointestinal, renal, or any disorder or history of a condition that would impact or interfere with drug absorption, distribution, metabolism, or excretion during the study or may interfere with the participants ability to participate in the study.
- Subject has family history of early cardiovascular disease or sudden death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTx-1301 - Dexmethylphenidate 25mgAlso: All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.25mg CTx-1301 (Dexmethylphenidate tablet) | Drug | 25mg CTx-1301 (Dexmethylphenidate tablet) |
| CTx-1301 - Dexmethylphenidate 37.5mgAlso: All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.37.5mg CTx-1301 (Dexmethylphenidate tablet) | Drug | 37.5mg CTx-1301 (Dexmethylphenidate tablet) |
| CTx-1301 - Dexmethylphenidate 50mgAlso: All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.50mg CTx-1301 (Dexmethylphenidate tablet) | Drug | 50mg CTx-1301 (Dexmethylphenidate tablet) |
| PlaceboAlso: Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomized phase.Placebo | Drug | Placebo |
Primary outcome
The Primary Efficacy Analysis Will Analyze the Change in PERMP Scores From Baseline (Pre-dose) at Visit 8 to Hour 16 at Visit 8.
Time frame: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hour 16 at Visit 8.
The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
2 secondary outcomes
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Time frame: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hours .5,1,3,6,9,12,13,14,15, and 16.
Key Secondary Analysis Will Analyze the Change From Baseline (Pre-dose at Visit 2) of Clinical Global Impression - Severity (CGI-S) Scores to CGI-S at Visit 8.
Time frame: Baseline (pre-dose at Visit 2) to Visit 8 (approximately 6 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Childress, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CTx-1301 - Dexmethylphenidate 25mg, CTx-1301 - Dexmethylphenidate 37.5mg and CTx-1301 - Dexmethylphenidate 50mg in people with ADHD and ADHD - Combined Type, run by Cingulate Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Efficacy Analysis Will Analyze the Change in PERMP Scores From Baseline (Pre-dose) at Visit 8 to Hour 16 at Visit 8. (time frame: Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hour 16 at Visit 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.