- |||||||||| 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
- |||||||||| 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
- |||||||||| 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
- |||||||||| Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma, Quillivant XR (methylphenidate extended release oral suspension) / Pfizer
Enrollment open: Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - Jun 10, 2014
P2, N=64, Recruiting,
Trial primary completion date: Jan 2018 --> Jan 2019 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
Enrollment closed: Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - May 18, 2014
P2, N=64, Active, not recruiting,
Not yet recruiting --> Recruiting 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
New P2 trial: Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - Jun 24, 2012
P2, N=64, Recruiting,
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