CLINICAL TRIALS PROFILE FOR AZSTARYS
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All Clinical Trials for azstarys
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03460652 ↗ | KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD | Completed | KemPharm, Inc. | Phase 3 | 2018-03-13 | This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD). |
| NCT05685732 ↗ | An Efficacy and Safety Study w/ Azstarys® in Children With ADHD | Not yet recruiting | Almac | Phase 4 | 2023-03-01 | This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate. |
| NCT05685732 ↗ | An Efficacy and Safety Study w/ Azstarys® in Children With ADHD | Not yet recruiting | Premier Research Group plc | Phase 4 | 2023-03-01 | This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate. |
| NCT05685732 ↗ | An Efficacy and Safety Study w/ Azstarys® in Children With ADHD | Not yet recruiting | Prometrika, LLC | Phase 4 | 2023-03-01 | This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate. |
| NCT05685732 ↗ | An Efficacy and Safety Study w/ Azstarys® in Children With ADHD | Not yet recruiting | Corium, Inc. | Phase 4 | 2023-03-01 | This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate. |
| NCT05721235 ↗ | An Open-Label Safety/Tolerability and PK Study With Azstarys® in Children With ADHD | Not yet recruiting | Almac | Phase 4 | 2023-05-01 | 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. |
| NCT05721235 ↗ | An Open-Label Safety/Tolerability and PK Study With Azstarys® in Children With ADHD | Not yet recruiting | Premier Research Group plc | Phase 4 | 2023-05-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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