Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301

ClinicalTrials.gov ID: NCT05286762
Sponsor: Cingulate Therapeutics
Information provided by: Cingulate Therapeutics (Responsible Party)
Last Update Posted: 2023-09-22

Brief Summary:
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.

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.

Official Title:
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

Intervention / Treatment:
- 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)
- Drug: CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose)
- Drug: Placebo

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