Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium 
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 0 Diseases   4 Trials   4 Trials   58 News 
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Enrollment open:  Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) -  Sep 18, 2023   
    P4,  N=30, Recruiting, 
    Determining the optimal dosage of SDX/d-MPH and its effect on ADHD severity could enable the development of a more clinically relevant treatment regimen in children with ADHD. Not yet recruiting --> Recruiting
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Enrollment open:  KP415P02: A Safety/Tolerability and PK Study With Azstarys (clinicaltrials.gov) -  May 26, 2023   
    P4,  N=100, Recruiting, 
    Statistically significant improvements in most CSHQ sleep domains were observed after 1 month and lasted for up to 12 months of treatment. Not yet recruiting --> Recruiting
  • ||||||||||  A Comprehensive Review of Novel FDA Approved Psychiatric Indications From 2018-2022 (Hall B Foyer, Exhibition Level Moscone South) -  May 17, 2023 - Abstract #APA2023APA_968;    
    Clinical trials for each medication suggested favorable results in Phase III trials that lead to approval, along with current success in Phase IV trials as well. In 2018, Lucemyra (lofexidine) was approved for the treatment of opioid withdrawal.
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Enrollment open:  KP415P01: An Efficacy and Safety Study w/ Azstarys (clinicaltrials.gov) -  Feb 22, 2023   
    P4,  N=230, Recruiting, 
    ClinicalTrials.gov identifier: NCT03460652. Not yet recruiting --> Recruiting
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    New P4 trial:  KP415P01: An Efficacy and Safety Study w/ Azstarys (clinicaltrials.gov) -  Jan 17, 2023   
    P4,  N=230, Not yet recruiting, 
  • ||||||||||  Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Journal:  New Drugs to Treat ADHD: Opportunities and Challenges in Research and Development. (Pubmed Central) -  Aug 7, 2022   
    Since the landmark MTA (Multimodal Treatment of ADHD) trial unequivocally demonstrated the efficacy of methylphenidate, catecholaminergic drugs, especially stimulants, have been the therapeutic mainstay in treatment of Attention-Deficit Hyperactivity Disorder (ADHD)...The substantial number of failures probably accounts for a continued focus on developing novel catecholaminergic and noradrenergic drugs, and a dearth of drug-candidates with novel mechanisms entering clinical development. However, substantial improvements in ADHD pharmacotherapy have been achieved by the almost exclusive use of once-daily medications and prodrugs, e.g. lisdexamfetamine and Azstarys, which improve compliance, deliver greater efficacy and reduce risks for diversion and abuse.
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Journal:  Azstarys (serdexmethylphenidate/dexmethylphenidate) for ADHD. (Pubmed Central) -  Oct 7, 2021   
    SDX/d-MPH was safe, with AEs comparable with those observed with other stimulant treatments. No abstract available
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Trial completion:  KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) -  Aug 18, 2019   
    P3,  N=282, Completed, 
    Studies were conducted in accordance with FDA Guidance on abuse potential (2017). Recruiting --> Completed
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Trial completion date, Trial primary completion date:  KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) -  Apr 22, 2019   
    P3,  N=250, Recruiting, 
    Recruiting --> Completed Trial completion date: Mar 2019 --> Jun 2019 | Trial primary completion date: Mar 2019 --> Jun 2019
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Trial completion:  KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) -  Jun 14, 2018   
    P3,  N=157, Completed, 
    Trial completion date: Mar 2019 --> Jun 2019 | Trial primary completion date: Mar 2019 --> Jun 2019 Active, not recruiting --> Completed
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Enrollment closed:  KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) -  Apr 9, 2018   
    P3,  N=140, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Trial completion date, Trial primary completion date:  KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) -  Mar 3, 2018   
    P3,  N=140, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Feb 2018 --> Apr 2018 | Trial primary completion date: Feb 2018 --> Apr 2018
  • ||||||||||  Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
    Enrollment open:  KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) -  Dec 7, 2017   
    P3,  N=140, Recruiting, 
    Trial completion date: Feb 2018 --> Apr 2018 | Trial primary completion date: Feb 2018 --> Apr 2018 Not yet recruiting --> Recruiting