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  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Enrollment change, Trial completion date, Trial suspension, Trial primary completion date:  Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (clinicaltrials.gov) -  Aug 15, 2024   
    P3,  N=45, Suspended, 
    N=82 --> 45 | Trial completion date: Apr 2024 --> Aug 2026 | Recruiting --> Suspended | Trial primary completion date: Jan 2024 --> Aug 2026
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial termination:  Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) -  Aug 14, 2024   
    P3,  N=103, Terminated, 
    N=82 --> 45 | Trial completion date: Apr 2024 --> Aug 2026 | Recruiting --> Suspended | Trial primary completion date: Jan 2024 --> Aug 2026 Active, not recruiting --> Terminated; Continuation of the study is not required for NDA submission via the 505(b)(2) pathway
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Enrollment closed, Enrollment change:  Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) -  Jan 23, 2024   
    P3,  N=99, Active, not recruiting, 
    Active, not recruiting --> Terminated; Continuation of the study is not required for NDA submission via the 505(b)(2) pathway Recruiting --> Active, not recruiting | N=385 --> 99
  • ||||||||||  Qelbree (viloxazine) / Supernus Pharma
    What (Rhinelander South (New York Hilton Midtown); In-person) -  Sep 30, 2023 - Abstract #AACAP2023AACAP_108;    
    Others in clinical trials include: dexmethylphenidate ER (CTX 1301), a stimulant designed to last up to 16 hours; L-threonic acid magnesium salt, a compound that has been shown to improve ADHD symptoms in adults; and solriamfetol, a dopamine and norepinephrine reuptake inhibitor that is FDA-approved for patients with narcolepsy. Conclusions Participants will gain a better understanding of the efficacy and safety of newly approved FDA products, as well as investigational products, for the treatment of ADHD.
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Enrollment open:  Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (clinicaltrials.gov) -  Aug 2, 2023   
    P3,  N=82, Recruiting, 
    Conclusions Participants will gain a better understanding of the efficacy and safety of newly approved FDA products, as well as investigational products, for the treatment of ADHD. Not yet recruiting --> Recruiting
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion date, Trial primary completion date:  Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (clinicaltrials.gov) -  May 10, 2023   
    P3,  N=25, Recruiting, 
    Recruiting --> Completed Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Enrollment open:  Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (clinicaltrials.gov) -  Jan 25, 2023   
    P3,  N=25, Recruiting, 
    Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Jun 2023 Not yet recruiting --> Recruiting
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion date, Trial initiation date, Trial primary completion date:  Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) -  Nov 4, 2022   
    P3,  N=312, Not yet recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Jun 2023 --> Dec 2023 | Initiation date: Dec 2022 --> Jun 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion:  Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects (clinicaltrials.gov) -  Oct 20, 2022   
    P1,  N=27, Completed, 
    Trial completion date: Jun 2023 --> Dec 2023 | Initiation date: Dec 2022 --> Jun 2023 | Trial primary completion date: Jun 2023 --> Dec 2023 Not yet recruiting --> Completed
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion date, Trial initiation date, Trial primary completion date:  Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) -  Aug 16, 2022   
    P3,  N=312, Not yet recruiting, 
    Not yet recruiting --> Completed Trial completion date: Dec 2022 --> Jun 2023 | Initiation date: Jul 2022 --> Dec 2022 | Trial primary completion date: Dec 2022 --> Jun 2023
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial initiation date:  Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) -  May 16, 2022   
    P3,  N=312, Not yet recruiting, 
    Trial completion date: Dec 2022 --> Jun 2023 | Initiation date: Jul 2022 --> Dec 2022 | Trial primary completion date: Dec 2022 --> Jun 2023 Initiation date: Apr 2022 --> Jul 2022
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion date, Trial primary completion date:  Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects (clinicaltrials.gov) -  Jan 5, 2022   
    P1,  N=26, Not yet recruiting, 
    Initiation date: Apr 2022 --> Jul 2022 Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Dec 2022
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion date, Trial initiation date, Trial primary completion date:  Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects (clinicaltrials.gov) -  Jun 23, 2021   
    P1,  N=26, Not yet recruiting, 
    Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Dec 2022 Trial completion date: Sep 2021 --> Mar 2022 | Initiation date: Jul 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Mar 2022
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Phase classification:  CTx-1301 Comparative Bioavailability Study (clinicaltrials.gov) -  Jul 22, 2020   
    P1/2,  N=45, Completed, 
    Trial completion date: Sep 2021 --> Mar 2022 | Initiation date: Jul 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Mar 2022 Phase classification: P1 --> P1/2
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Phase classification:  CTx-1301 Comparative Bioavailability Study (clinicaltrials.gov) -  Jun 18, 2020   
    P1,  N=45, Completed, 
    Phase classification: P1 --> P1/2 Phase classification: P1/2 --> P1
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Trial completion:  CTx-1301 Comparative Bioavailability Study (clinicaltrials.gov) -  Mar 10, 2020   
    P1/2,  N=45, Completed, 
    Phase classification: P1/2 --> P1 Recruiting --> Completed
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    Enrollment open:  CTx-1301 Comparative Bioavailability Study (clinicaltrials.gov) -  Nov 20, 2019   
    P1/2,  N=36, Recruiting, 
    Recruiting --> Completed Not yet recruiting --> Recruiting
  • ||||||||||  dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap
    New P1/2 trial:  CTx-1301 Comparative Bioavailability Study (clinicaltrials.gov) -  Nov 4, 2019   
    P1/2,  N=36, Not yet recruiting,