Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 10:12 PM
Ignite Modification Date: 2025-12-24 @ 10:12 PM
NCT ID: NCT05721235
Brief Summary: The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.
Detailed Description: • Screening Period: New subjects will undergo a Screening Period up to 30 days prior to entering the Dose Optimization Phase. • Dose Optimization Phase: During the 3-week Dose Optimization Phase, subjects will start at 13.1 mg/2.6 mg, and may be titrated to doses of 26.1 mg/5.2 mg or 39.2 mg/7.8 mg Azstarys® capsules based on individual tolerability and best dose-response in the opinion of the Investigator. • Treatment Phase: Eligible subjects will receive single daily doses of Azstarys® for approximately 360 ±20 days (approximately 12 months). The starting dose of Azstarys® in the Treatment Phase will be the same as the optimized dose of Azstarys® at the end of the Dose Optimization Phase, either 13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day. The daily dose may be changed at any time to any of the allowed dose levels (13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day) at the Investigator' discretion, based on individual tolerability and dose response.
Study: NCT05721235
Study Brief:
Protocol Section: NCT05721235