Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatric... | NCT05286762

NCT05286762

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

A Phase 3, double-blind, randomized, placebo-controlled, multi-center, fixed-dose, parallel group efficacy and safety study in pediatrics (6-17) with ADHD diagnosis confirmed by an ADHD-RS-5 score of at least 28 and CGI-S score of at least 4 (moderately ill) at screening. The study will be comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit.

The Study will be comprised of 3 periods:

Screening Period (Day -30 to Day -1): Subjects will undergo a Screening Visit (Visit 1) up to 30 days prior to entering the randomized treatment period. Only subjects that meet all inclusion and no exclusion criteria at screening may be considered for entry/randomization into the study. A reminder telephone call will be completed 5 days prior to Day 0 (Visit 2) to ensure washout of current prohibited medications, to confirm inclusion/exclusion criteria, and to confirm date of next visit.
Randomized Treatment Period (Day 0 to Day 35 +/- 3 days): Subjects will be randomized on Day 0 to active or placebo (placebo, CTx-1301 18.75 mg, CTx-1301 25 mg, or CTx-1301 37.5 mg). Subjects randomized to the active dose will have a starting dose of 12.5 mg on Day 0. Each subject randomized to an active dose will be titrated (increased) weekly until they reach their assigned fixed dose; subjects must be on their assigned fixed dose a minimum of 2 sequential weeks prior to the primary efficacy assessment at Week 5/Visit 8. Subjects will be instructed to take their dose every morning at-home upon waking, no later than 8:00 am.
Safety Follow-Up Visit (Day 42 +/- 5 days): Subjects will be evaluated for safety after washout of medication.

Subjects will participate in the study as outpatients for up to approximately 10 weeks (including screening); a 30-day screening period, a 5-week double-blind randomized period, and a 1-week follow-up safety visit.

Completion of the primary study is defined as LSLV at Visit 9.

Subjects will be randomized at baseline to CTx-1301 or placebo (CTx-1301 18.75 mg, CTx-1301 25 mg, CTx-1301 37.5 mg, or placebo). Starting dose for subjects randomized to active treatment is 12.5 mg. These subjects will then be titrated up to their assigned fixed dose (18.75, 25, or 37.5 mg) for the last two weeks of the study period. Subjects randomized to placebo will receive placebo treatment for the full 5 weeks of the study.

Sparse PK sampling will be conducted after a single dose and at steady state from the patient population with special attention given to the time the sample is obtained post-dose. These analyses will inform strategies that manage dosing and detail administration for a given subpopulation, planned subsequent studies, and support labeling.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18.75 mg CTx-1301 (dexmethylphenidate tablet)	Active Comparator	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.	Drug: CTx-1301-Dexmethylphenidate 12.5 mg (titration only) Drug: CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose)
25 mg CTx-1301 (dexmethylphenidate tablet)	Active Comparator	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.	Drug: CTx-1301-Dexmethylphenidate 12.5 mg (titration only) Drug: CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose) Drug: CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose)
37.5 mg CTx-1301 (dexmethylphenidate tablet)	Active Comparator	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.	Drug: CTx-1301-Dexmethylphenidate 12.5 mg (titration only)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTx-1301-Dexmethylphenidate 12.5 mg (titration only)	Drug	Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg	18.75 mg CTx-1301 (dexmethylphenidate tablet)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	The Attention Deficit Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) overall scores range from 0-54; an improvement from Baseline is defined as a decrease in the overall score.	Baseline (Day 0) to Week 5 (Visit 8)

Secondary Outcomes

Measure	Description	Time Frame
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.	The Clinical Global Impression - Severity (CGI-S) is a single score ranging from 1-7; an improvement from Baseline is defined as a decrease in the score.	Baseline (Day 0) to Week 5 (Visit 8)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects between 6 and 17 years of age (inclusive) at the time of Randomization (Visit 2). Subjects who are expected to turn 18 years of age during the trial will not be allowed.
Subject must have a body weight between the 5th and 95th percentile (≥5th percentile and ≤95th percentile) for their respective age and sex.
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.
Subjects of child-bearing potential at screening or that become of child-bearing potential during the study must agree to remain abstinent or agree to use a highly effective, medically acceptable form of birth control for the time of written assent and for at least 30 days after the last dose of study drug has been taken (females). 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. Child-bearing potential is defined as any female who has had their first period or is 12 years or older (or will be 12 while in the study).
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 (QTc less than or equal to 460 milliseconds), medical history, and laboratory values (hematology, chemistry, serology, TSH, 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 age-appropriate level, as deemed by the Investigator.
Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for the primary diagnosis of ADHD or any of the three presentations (combined, inattentive, or hyperactive/impulsive presentation) upon clinical evaluation and confirmed by the MINI International Neuropsychiatric Interview of Children and Adolescents (MINI-KID). The MINI should also be used to evaluate any other psychotic disorders.
Subject must score 28 or higher on the ADHD-RS-5 scale 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 Baseline (Visit 2).
Subject must be able and willing to wash out of stimulant ADHD medications (except study drug as indicated per protocol), including herbal medication, from 5 days prior to the start of the randomized phase (Visit 2) and for the duration of the entire study, defined as completion of the safety follow-up visit (approximately 1.25 months, excluding screening). Additionally, subject must be able and willing to wash out from non-stimulant ADHD medications 21 days prior to the start of the randomized phase (Visit 2) and for the duration of the entire study (approximately 1.25 months, excluding screening), defined as completion of the safety follow-up visit.
Subject and parent/legal guardian, and/or caregiver (if applicable) 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 and parent/legal guardian, and/or caregiver (if applicable) must plan to be available for the entire duration of the study.
One or more of the parents/legal guardians/caregivers of the subject must voluntarily give written permission for him/her to participate in the study.
Subject must provide written assent prior to study participation.
Subject, subject's parent/legal guardian, and/or caregiver (if applicable) must understand and be willing and able to comply with study procedures as well as the visit schedule. If the subject is cared for by a caregiver for relevant portions of the day, the caregiver may be more suitable for certain assessments, and the caregiver will need to agree to the applicable procedures and visits.
Subject must be able to swallow the CTx-1301 tablet as evidenced by ability to swallow a similar size tablet (placebo) at screening.

Exclusion Criteria:

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, defined as completion of safety visit at the end of study (Visit 9). 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, major depressive disorder, conduct disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, obsessive-compulsive disorder, eating disorder, anxiety disorder (including generalized anxiety disorder), any history of psychosis, autism spectrum disorder, a history of motor or vocal tics or 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/uncontrolled medical abnormality or 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 of any lifetime history on the C-SSRS Children's Lifetime/Recent assessment at screening.
Subject has history of seizures, excluding febrile seizures.
Subject has a known primary sleep disorder (e.g., sleep apnea, narcolepsy, etc.)
If the subject's blood pressure is < 90th percentile for their age, sex, and height, the single read is sufficient. If the subject's blood pressure is ≥ 90th percentile, two additional reads will be taken, and the three reads will be averaged. If the average of the three readings is ≥ 95th percentile at screening they will be excluded.
Subject is considered treatment refractory by the Investigator or is intolerant to stimulant ADHD mediation.
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 use or has a positive urine drug screen at Screening or Baseline. 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.
Previous treatment experience/exposure to CTx-1301.
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 participated in any other clinical study with an investigational drug/product within 30 days prior to Screening or is currently participating in another clinical study.
Subject's family 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.
Subject is a family member of an employee 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.

Contacts/Locations Module

Name	Affiliation	Role
Matt Brams, MD	Cingulate	Study Director
Ann Childress, MD	Center for Psychiatry And Behavioral Medicine Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Neuroscience Solutions, Inc.		Jacksonville	Florida	32256	United States
Meridien Research

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 13, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Drug: CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose)

Drug: CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose)

Drug: CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose)

25 mg CTx-1301 (dexmethylphenidate tablet)

37.5 mg CTx-1301 (dexmethylphenidate tablet)

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
BG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
BG002	37.5 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
BG003	Placebo	Subjects randomized to placebo will be on placebo for the full 5 weeks of the study. Placebo: Subjects will be randomized at Visit 2 to Placebo
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

6-12 Years

Title	Measurements
	BG00016 BG00116 BG00216 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00013 BG00110 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00026 BG00126 BG002

BMI Z-Score

BMI Z-scores were calculated using the CDC source code SAS program. BMI z-scores for children measure how a child's BMI compares to to other children of the same age and sex, indicating if they are underweight, healthy, overweight, or obese based on standard deviations (SD) from the average (z-score of 0). Positive scores are above average (greater than or equal to 1 SD for overweight, greater than or equal to 2 SD for obesity), and negative scores are below average (less than or equal to -2 SD for thinness).

Mean

Standard Deviation

Z-Score

Title

Denominators

Categories

Title	Measurements
	BG0000.413± 0.8340 BG001

BMI Percentile

BMI percentiles were calculated using the CDC source code SAS program.

Mean

Standard Deviation

Percentile

Title

Denominators

Categories

Title	Measurements
	BG00062.84± 27.212 BG00156.31± 31.410

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The Attention Deficit Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) overall scores range from 0-54; an improvement from Baseline is defined as a decrease in the overall score.

Summary of observed values and changes from Baseline to Week 5 in the ADHD-RS-5 total score for all subjects (Intent-to-Treat Set).

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 0) to Week 5 (Visit 8)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
OG002	37.5 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
OG003	Placebo	Subjects randomized to placebo will be on placebo for the full 5 weeks of the study. Placebo: Subjects will be randomized at Visit 2 to Placebo

Units	Counts
Participants	OG00021 OG00122 OG00220 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-18.0± 12.24 OG001-17.8± 12.78 OG002-22.0± 15.07 OG003

Secondary

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.

The Clinical Global Impression - Severity (CGI-S) is a single score ranging from 1-7; an improvement from Baseline is defined as a decrease in the score.

Summary of CGI-S score and change from Baseline to Week 5 for all subjects (Intent-to Treat Set)

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 0) to Week 5 (Visit 8)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Number of Subjects With Clinically Significant Changes in Vital Signs That Resulted in an Adverse Event.

Vital signs will be evaluated in each in-office visit; clinically significant changes will be recorded as an adverse event.

Posted

Count of Participants

Participants

Baseline to Visit 8 (5 weeks)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Number of Subjects With Clinically Significant Changes in Blood Labs That Resulted in an Adverse Event.

Safety labs will be taken at Screening to determine eligibility for entry into the study; safety labs are assessed again at Visit 8 and any clinically significant change from Screening labs will be recorded as an adverse event.

Posted

Count of Participants

Participants

Screening to Visit 8 (approximately 5-9 weeks, depending on screening window)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Number of Subjects With Clinically Significant Changes in Physical Exam Findings That Resulted in an Adverse Event.

Physical exams will be conducted at Screening, Baseline, and Visit 8. Changes noted as clinically significant from Baseline to Visit 8 will be recorded as an adverse event.

Posted

Count of Participants

Participants

Baseline to Visit 8 (5 weeks)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Number of Subjects With Clinically Significant Changes in Height and Weight BMI That Resulted in an Adverse Event.

Height and Weight (BMI) will be evaluated at all in-office visits. Any clinically significant change in BMI from Baseline to Visit 8 will be recorded as an AE.

Posted

Count of Participants

Participants

Baseline to Visit 8 (5 weeks)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Number of Subjects With Clinically Significant Changes in C-SSRS Findings That Resulted in an Adverse Event.

C-SSRS will be conducted at all in-office visits. Any clinically significant change from Baseline (at any visit) will be reported as an AE.

Posted

Count of Participants

Participants

Baseline to Visit 8 (5 weeks)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Number of Subjects With Clinically Significant Changes in ECG Findings That Resulted in an Adverse Event.

ECGs will be taken at Screening to determine eligibility for entry into the study; ECGs are assessed again at Visit 8 and any clinically significant change from Screening ECG will be recorded as an adverse event.

Posted

Count of Participants

Participants

Screening to Visit 8 (approximately 5-9 weeks, depending on screening window)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Secondary

Safety - Incidence of TEAEs

Treatment Emergent Adverse Events will be evaluated at each visit.

Overall summary of adverse events (Safety Set)

Posted

Count of Participants

Participants

Screening to Visit 9 (approximately 6-10 weeks, depending on screening window)

ID	Title	Description
OG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
OG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	18.75 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg	26	26	13	26
EG001	25 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg	26	26	9	26
EG002	37.5 mg CTx-1301 (Dexmethylphenidate Tablet)	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. CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg	25	25	17	25
EG003	Placebo	Subjects randomized to placebo will be on placebo for the full 5 weeks of the study. Placebo: Subjects will be randomized at Visit 2 to Placebo	26	26	10	26

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected26 at risk EG0025 events4 affected25 at risk EG0032 events2 affected26 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Tooth disorder	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 events3 affected26 at risk EG0015 events5 affected26 at risk EG0027 events7 affected25 at risk EG003
Blood pressure increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0002 events1 affected26 at risk EG0010 events0 affected26 at risk EG0023 events2 affected25 at risk EG003
Blood pressure diastolic increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0012 events1 affected26 at risk EG0020 events0 affected25 at risk EG003
Weight decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0022 events2 affected25 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Blood pressure systolic increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected26 at risk EG0021 events1 affected25 at risk EG003
Bronchitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Impetigo	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Otitis media	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Parotitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Sinusitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0012 events1 affected26 at risk EG0020 events0 affected25 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0012 events2 affected26 at risk EG0020 events0 affected25 at risk EG003
Irritability	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0012 events2 affected26 at risk EG0020 events0 affected25 at risk EG003
Aggression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected26 at risk EG0020 events0 affected25 at risk EG003
Depression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Major depression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Headache	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 events3 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Lethargy	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Tremor	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected26 at risk EG0020 events0 affected25 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0012 events2 affected26 at risk EG0021 events1 affected25 at risk EG003
Palpitations	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected26 at risk EG0021 events1 affected25 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Chest pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Pyrexia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Thirst	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Diastolic hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected26 at risk EG0020 events0 affected25 at risk EG003
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0021 events1 affected25 at risk EG003
Prehypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected26 at risk EG0020 events0 affected25 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected26 at risk EG0020 events0 affected25 at risk EG003
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected26 at risk EG0020 events0 affected25 at risk EG003

First MCP Posted Date

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

ID	Term
D011897	Random Allocation

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders