Quillivant XR (methylphenidate extended release oral suspension) / Pfizer 
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  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial completion date, Trial primary completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  May 31, 2024   
    P2,  N=68, Active, not recruiting, 
    Trial completion date: Jun 2028 --> Dec 2025 | Trial primary completion date: Jun 2028 --> Dec 2025
  • ||||||||||  Jornay PM (methylphenidate extended release) / Highland Therapeutics
    Trial completion date, Trial primary completion date:  Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) -  Apr 17, 2024   
    P4,  N=226, Recruiting, 
    Trial completion date: Jun 2028 --> Dec 2025 | Trial primary completion date: Jun 2028 --> Dec 2025 Trial completion date: Mar 2028 --> Sep 2027 | Trial primary completion date: Jun 2027 --> Sep 2027
  • ||||||||||  Jornay PM (methylphenidate extended release) / Highland Therapeutics
    Enrollment open:  Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) -  Aug 21, 2023   
    P4,  N=226, Recruiting, 
    Trial completion date: Mar 2028 --> Sep 2027 | Trial primary completion date: Jun 2027 --> Sep 2027 Not yet recruiting --> Recruiting
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial completion date, Trial primary completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  Jul 5, 2023   
    P2,  N=68, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Jun 2023 --> Jun 2028 | Trial primary completion date: Jun 2023 --> Jun 2028
  • ||||||||||  Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Phase classification, Enrollment change:  DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) -  May 31, 2023   
    P4,  N=100, Recruiting, 
    Trial completion date: Jun 2023 --> Jun 2028 | Trial primary completion date: Jun 2023 --> Jun 2028 Phase classification: P1/2 --> P4 | N=30 --> 100
  • ||||||||||  Jornay PM (methylphenidate extended release) / Highland Therapeutics
    Trial completion date, Trial primary completion date:  Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) -  Jan 26, 2023   
    P4,  N=226, Not yet recruiting, 
    Phase classification: P1/2 --> P4 | N=30 --> 100 Trial completion date: Dec 2027 --> Mar 2028 | Trial primary completion date: Dec 2026 --> Jun 2027
  • ||||||||||  Jornay PM (methylphenidate extended release) / Highland Therapeutics
    Enrollment change, Trial completion date, Trial primary completion date:  Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) -  Oct 21, 2022   
    P4,  N=226, Not yet recruiting, 
    Trial completion date: Dec 2027 --> Mar 2028 | Trial primary completion date: Dec 2026 --> Jun 2027 N=77 --> 226 | Trial completion date: Mar 2027 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2026
  • ||||||||||  Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial completion date, Trial primary completion date:  DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) -  Oct 20, 2022   
    P1/2,  N=30, Recruiting, 
    N=77 --> 226 | Trial completion date: Mar 2027 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2026 Trial completion date: Jan 2022 --> Aug 2025 | Trial primary completion date: Jan 2022 --> Aug 2025
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial completion date, Trial primary completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  Oct 4, 2021   
    P2,  N=64, Active, not recruiting, 
    Trial completion date: Jan 2022 --> Aug 2025 | Trial primary completion date: Jan 2022 --> Aug 2025 Trial completion date: Jun 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2023
  • ||||||||||  Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Enrollment open:  DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) -  Oct 26, 2020   
    P1/2,  N=30, Recruiting, 
    Trial completion date: Jun 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2023 Not yet recruiting --> Recruiting
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial primary completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  Aug 24, 2020   
    P2,  N=68, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial primary completion date: Jun 2020 --> Jun 2021
  • ||||||||||  Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial initiation date:  DS+ADHD Pilot: Evaluating Treatment of ADHD in Children With Down Syndrome (clinicaltrials.gov) -  Jul 14, 2020   
    P1/2,  N=30, Not yet recruiting, 
    Trial primary completion date: Jun 2020 --> Jun 2021 Initiation date: Jan 2020 --> Aug 2020
  • ||||||||||  Ritalin (methylphenidate tablet) / Generic mfg.
    Are Differences in Long-Acting Stimulant Formulations Clinically Meaningful? (Lincoln 2-4) -  Dec 12, 2019 - Abstract #APSARD2020APSARD_104;    
    Methylphenidate (MPH) ER requires additional PK measures– namely, partial exposure/AUC (pAUC) measures...The main aim of this dose-optimized, double-blind, randomized, placebo-controlled, cross-over analogue classroom study was to address BE in pharmacodynamic (PD) effects between MPH ER formulations intended to be similar in PK (e.g., OROS MPH (Concerta), Mallinckrodt generic) compared to a MPH ER formulation with a different PK profile, Quillivant XR...Learning Objective 1: To gain familiarity on FDA requirements for Bioequivalence in MPH ER formulations. Learning Objective 2: To understand clinical implications of differing PK profiles in MPH ER formulations.
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  May 24, 2019   
    P2,  N=68, Active, not recruiting, 
    There was no difference in overall rate or extent of exposure of methylphenidate when MPH ERCT was chewed versus swallowed whole by healthy volunteers. Trial completion date: Jun 2020 --> Jun 2021
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial completion date, Trial primary completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  Apr 20, 2019   
    P2,  N=68, Active, not recruiting, 
    Trial completion date: Jun 2020 --> Jun 2021 Trial completion date: Jan 2019 --> Jun 2020 | Trial primary completion date: Jan 2019 --> Jun 2020
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Enrollment closed:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  Jun 21, 2017   
    P2,  N=68, Active, not recruiting, 
    Trial completion date: Jan 2019 --> Jun 2020 | Trial primary completion date: Jan 2019 --> Jun 2020 Recruiting --> Active, not recruiting
  • ||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
    Trial primary completion date:  Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) -  Feb 6, 2017   
    P2,  N=64, Recruiting, 
    Recruiting --> Active, not recruiting Trial primary completion date: Jan 2018 --> Jan 2019