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About
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.
Full description
A Phase 3, dose-optimized, randomized, double-blind, placebo-controlled, dose-optimized, parallel efficacy and safety laboratory classroom study in children (6-12) 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 into a 8-week dose-optimization phase. During the dose-optimization phase, subjects will have weekly visits and will be titrated to doses ranging between 6.25mg-37.5mg of CTx-1301. Eligible subjects will be randomized phase to their optimal dose or placebo in a 1:1 ratio at the end of Visit 10 completing the practice laboratory classroom study. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th days subjects will complete the full laboratory classroom study. The duration of the full laboratory classroom study will be approximately 15 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full classroom day.
Enrollment
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Inclusion criteria
Exclusion criteria
Eligibility Criteria (end of dose-optimization phase)
Subjects will be required to meet the following additional eligibility criteria at the end of the dose-optimization phase (Visit 10) to enter into the double-blind, randomized phase. These criteria are based on the efficacy and safety observed over the 8-week dose-optimization period.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 7 patient groups, including a placebo group
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Central trial contact
Kelly Kramer AD, Clinical Operations
Data sourced from clinicaltrials.gov
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