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A Phase 3, randomized, double-blind, placebo-controlled, multi-center, fixed-dose, parallel-group efficacy and safety study in a pediatric population (6-17) with Attention-Deficit/Hyperactivity Disorder (ADHD) using CTx-1301 (d-MPH). The study will be comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit.
Full 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:
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.
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Interventional model
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103 participants in 4 patient groups, including a placebo group
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Central trial contact
Kelly Koehn; Amy Salem AD, Clinical Operations
Data sourced from clinicaltrials.gov
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