Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (NCT05924594) | Clinical Trial Compass
SuspendedPhase 3
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
Stopped: Continuation of the study is not required for NDA submission via the 505(b)(2) pathway
United States45 participantsStarted 2023-07-31
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting.
Who can participate
Age range6 Years – 12 Years
SexALL
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Inclusion criteria
✓. Male or female subjects between 6 and 12 years of age (inclusive) at the time of consent.
✓. 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 or are newly diagnosed with ADHD is permitted.
✓. Females of childbearing potential must have a negative serum b-human chorionic gonadotropin pregnancy test at Screening. Child-bearing potential is defined as any female who has had their first period or is 12 years or older (or will be 12 during the study). Female of childbearing potential or that become child-bearing potential during the study must agree to use a highly effective, medically acceptable form of birth control for 30 days prior to Screening until at least 30 days after the last dose of study drug. Alternatively, subject may remain abstinent until at least 30 days after the last dose of study drug. Episodic abstinence is not reliable to avoid pregnancy, so is not considered a highly effective contraceptive method. Investigator discretion should use judgement and familiarity with the subject's "preferred and usual lifestyle" to assess if reporting of abstinence may be trusted to achieve required effectiveness. 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 significant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and safety laboratory tests at screening. If any of the exams or tests are not within the laboratory reference range, the Investigator must assess and determine if clinically significant.
✓. Subject's intellectual function is at an age-appropriate level, as deemed by the Investigator.
What they're measuring
1
Change from baseline (pre-dose measured at Day 63) of the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-combined scores collected across the 14-hour classroom day.
Timeframe: Baseline (pre-dose at Day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on Day 63.
✓. Subjects need to be able to perform at least the basic level of problems on the PERMP pre-test with at least 5.5 questions answered correctly per minute 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 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-KID should also be used to evaluate any other psychotic disorders.
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. 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 (excluding febrile seizures), 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, 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 subject's ability to participate in the study.
✕. Subject has family history of early cardiovascular disease or sudden death.
✕. Subject has any history of attempted suicide, 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 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.