Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (NCT05631626) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
United States21 participantsStarted 2022-12-29
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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).
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, 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.
✕
What they're measuring
1
The primary efficacy analysis will analyze the change in PERMP scores from Baseline (pre-dose) at Visit 8 to hour 16 at Visit 8.
Timeframe: Average of the change of the PERMP scores from baseline (measured pre-dose at Visit 8) to hour 16 at Visit 8.