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Last Updated: November 7, 2024

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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for azstarys

Condition Name

Condition Name for azstarys
Intervention Trials
Attention Deficit/Hyperactivity Disorder 2
ADHD 1
Adult Attention Deficit Hyperactivity Disorder 1
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Condition MeSH

Condition MeSH for azstarys
Intervention Trials
Attention Deficit Disorder with Hyperactivity 4
Hyperkinesis 2
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Clinical Trial Locations for azstarys

Trials by Country

Trials by Country for azstarys
Location Trials
United States 12
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Trials by US State

Trials by US State for azstarys
Location Trials
New York 1
Texas 1
Tennessee 1
Oregon 1
Ohio 1
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Clinical Trial Progress for azstarys

Clinical Trial Phase

Clinical Trial Phase for azstarys
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for azstarys
Clinical Trial Phase Trials
Not yet recruiting 2
Recruiting 1
Completed 1
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Clinical Trial Sponsors for azstarys

Sponsor Name

Sponsor Name for azstarys
Sponsor Trials
Corium, Inc. 3
Almac 2
Premier Research Group plc 2
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Sponsor Type

Sponsor Type for azstarys
Sponsor Trials
Industry 6
Other 6
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