Adhansia XR (methylphenidate extended release capsule) / Purdue - LARVOL DELTA

A Phase IV, Dose Optimized, Open Label, Evaluation of the Effect of Multilayer Release Methylphenidate (MLR-MPH) on Sleep in Children Aged 6-12 with Attention Deficit Hyperactivity Disorder (CADDRA ADHD 2024) - "A mean increase in 10.5 minutes in sleep onset latency was found. The impact of methylphenidate on sleep was found to be highly individualized. Some participants had improved sleep, while others had significantly worsened sleep, and some had no change at all."

Clinical • P4 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Evening Quality of Life in Adults with ADHD following Treatment with PRC-063 or Lisdexamfetamine (CADDRA ADHD 2024) - "Objective: To examine the impact in evening-related quality of life in adults with ADHD following treatment with PRC-063 (methylphenidate hydrochloride controlled-release capsules) and lisdexamfetamine (LDX), as used in real-world clinical practice. The results of this real-world study confirm that dose optimized treatment with long-acting stimulants can result in improved evening quality of life within 1 month and maintained out to 4 months in adults with ADHD. Application to clinical and/or educational practice 1. Identify the greatest evening-related quality of life challenges in untreated adult ADHD."

Clinical • HEOR • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Post-Hoc Analysis of Clinical Data by Gender in Adults, Adolescents and Children with ADHD (CADDRA ADHD 2024) - "Objective: To conduct a post-hoc analysis of clinical data on PRC-063 (methylphenidate hydrochloride controlled-release capsules) by gender in adults and children with ADHD. When clinical data was summarized by gender, male and female participants were of similar age and baseline ADHD severity. Both male and female participants had similar optimized daily doses of PRC-063 and had similar improvements in ADHD symptomatology. Participant gender did not lead to a differential response to PRC-063."

Clinical data • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Mar 2028 ➔ Sep 2027 | Trial primary completion date: Jun 2027 ➔ Sep 2027

Trial completion date • Trial primary completion date • CNS Disorders • Cognitive Disorders • Epilepsy

A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD. (PubMed, J Atten Disord) - "The incidence of treatment-emergent adverse events was similar for each treatment sequence. PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured."

Clinical • Journal • P3 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity (clinicaltrials.gov) - P4 | N=60 | Completed | Sponsor: McMaster University | Unknown status ➔ Completed | Trial completion date: Mar 2021 ➔ Oct 2022

Trial completion • Trial completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry • Social Anxiety Disorder

Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD (clinicaltrials.gov) - P4 | N=41 | Active, not recruiting | Sponsor: JPM van Stralen Medicine Professional | Recruiting ➔ Active, not recruiting | N=29 ➔ 41 | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Recruiting | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Cognitive Disorders • Epilepsy

RE-DAX: Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P4 | N=267 | Terminated | Sponsor: Purdue Pharma LP | N=416 ➔ 267 | Completed ➔ Terminated; (due to administrative reasons not related to efficacy or safety.)

Enrollment change • HEOR • Real-world • Real-world effectiveness • Real-world evidence • Trial termination • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Real-World Efficacy and Safety of Extended-Release Methylphenidate (PRC-063) in the Treatment of ADHD in Pediatric and Adult Subjects: Results of a Phase IV Multicenter Comparison With Lisdexamfetamine Dimesylate. (PubMed, J Atten Disord) - "Significant improvements were demonstrated in quality of life and functionality. Both medications were well-tolerated; more adverse events led to study discontinuation in pediatric subjects treated with LDX versus PRC-063. PRC-063 and LDX significantly improved ADHD symptomatology and functioning and were well-tolerated."

Journal • P4 data • Real-world • Real-world effectiveness • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

"Foquest کودکان پیک اولیه 2-1.5 ساعت، پیک ثانویه 11-9 بزرگسالان پیک اولیه 1.6 ساعت، پیک ثانویه 16-11 ساعت قبل از مراجعه به داروخانه‌ها حتما با آنها تماس بگیرید @merck #hospitalized" (@sait11859965)

Clinical

Efficacy and Safety of PRC-063 for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis From Randomized Controlled Trials. (PubMed, J Atten Disord) - "A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. In subgroup analysis according to age, PRC-063 was more efficacious in minors compare to adults. PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents."

Journal • Retrospective data • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry • Sleep Disorder

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2027 ➔ Mar 2028 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • CNS Disorders • Cognitive Disorders • Epilepsy

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (clinicaltrials.gov) - P4 | N=226 | Not yet recruiting | Sponsor: VA Office of Research and Development | N=77 ➔ 226 | Trial completion date: Mar 2027 ➔ Dec 2027 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Cognitive Disorders • Epilepsy

"Foquest کودکان پیک اولیه 2-1.5 ساعت، پیک ثانویه 11-9 ساعت، بزرگسالان پیک اولیه 1.6 ساعت، پیک ثانویه 16-11 ساعت قبل از مراجعه به داروخانه‌ها حتما با آنها تماس بگیرید @merck #hospitalized" (@sait11859965)

Clinical

""کپسول کنترل رهش Biphentin (کودکان 2.4 ساعت، بزرگسالان 2.1 ساعت)، Foquest (بزرگسالان 3.25±6.95) کپسول پیوسته رهش 7-4 ساعت (Ritalin LA کودکان 4-1.5 ساعت، بزرگسالان 4.2-3 ساعت) قرص جویدنی پیوسته رهش 5.2 ساعت قبل از مراجعه به داروخانه‌ها حتما با آنها تماس بگیرید @merck #bleeding"" (@rahadani1)

Phase IV, Pragmatic, Open-Label, Real World Evidence Study of Methylphenidate Hydrochloride Controlled-Release Capsules (PRC-063) and Lisdexamfetamine Dimesylate for Treatment of Pediatric and Adult ADHD (CADDRA ADHD 2022) - "The results of this real-world study confirm that PRC-063 and LDX were effective and well-tolerated treatments for patients with ADHD. Between-treatment imbalance in baseline characteristics may have affected non-inferiority results. The side effect profiles were similar between treatments and between patient populations."

Clinical • HEOR • P4 data • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Pediatrics • Psychiatry • Sleep Disorder

Secondary Outcomes in a Pragmatic, Real World Evidence Study of Methylphenidate HCl (PRC-063) and Lisdexamfetamine Dimesylate for Treatment of Pediatric and Adult ADHD (CADDRA ADHD 2022) - "The real-world secondary outcomes confirm that both PRC-063 and LDX were effective and well-tolerated treatments for patients with ADHD. Significant improvements in functional outcomes related to daily activities, evening quality of life and patient satisfaction were reported."

Clinical • HEOR • Real-world evidence • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Analysis of Daily Sleep Diary Measures From Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children and Adults With ADHD. (PubMed, J Atten Disord) - "When compared with the diaries of placebo patients, the sleep diaries in both pediatric and adult patients showed no statistical difference in total sleep time, efficiency, or latency. PRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

""کپسول کنترل رهش Biphentin (کودکان 2.4 ساعت، بزرگسالان 2.1 ساعت)، Foquest (بزرگسالان 3.25±6.95) کپسول پیوسته رهش 7-4 ساعت (Ritalin LA کودکان 4-1.5 ساعت، بزرگسالان 4.2-3 ساعت) قرص جویدنی پیوسته رهش 5.2 ساعت"@merck #bleeding" (@hamed03905919)

"Foquest کودکان پیک اولیه 2-1.5 ساعت، پیک ثانویه 11-9 ساعت، بزرگسالان پیک اولیه 1.6 ساعت، پیک ثانویه 16-11 ساعت@merck #hospitalized" (@hamed03905919)

Clinical

Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children (clinicaltrials.gov) - P4 | N=105 | Terminated | Sponsor: Purdue Pharma LP | N=159 ➔ 105 | Trial completion date: Jul 2023 ➔ Apr 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2023 ➔ Apr 2022; due to administrative reasons not related to efficacy or safety.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD (clinicaltrials.gov) - P4 | N=29 | Recruiting | Sponsor: JPM van Stralen Medicine Professional | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children (clinicaltrials.gov) - P4 | N=159 | Active, not recruiting | Sponsor: Purdue Pharma LP | Recruiting ➔ Active, not recruiting

Enrollment closed • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

RE-DAX: Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P4 | N=416 | Completed | Sponsor: Purdue Pharma LP | Active, not recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Jan 2022

HEOR • Real-world evidence • Trial completion • Trial completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry