Evidence map›Paper›PMID 34189995›Full record

Trial reportJournal of attention disorders2022

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD.

Ann Childress, Andrew J Cutler, Andrea H Marraffino, Sailaja Bhaskar, Graeme Donnelly

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of attention disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03618030 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03618030 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD

TypeinterventionalSponsorPurdue Pharma, CanadaRan2018 to 2019Enrolled288ConditionsADHDArmsPRC-063 oral capsules, Placebo oral capsules
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 2 countries.

Ann ChildressCenter for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
Andrew J CutlerSUNY Upstate Medical University and Neuroscience Education Institute, Lakewood Ranch, FL, USA.
Andrea H MarraffinoMeridien Research, Maitland, FL, USA.ORCID 0000-0002-6241-6189
Sailaja BhaskarImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, CT, USA.
Graeme DonnellyPurdue Pharma (Canada), Pickering, Ontario, Canada.ORCID 0000-0002-7664-6436
Center for Psychiatry and Behavioral Medicine · USMeridien Research · USPurdue Pharma (Canada) · CAPurdue Pharma (United States) · USSUNY Upstate Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy, safety, and duration of action of the once-daily extended-release methylphenidate formulation PRC-063 for the treatment of ADHD in an adult laboratory classroom (ALC).

methodAfter dose optimization with PRC-063 over 7 weeks, adults with ADHD were randomized to 1 week of double-blind treatment with PRC-063 or placebo that ended with an ALC evaluation. The primary outcome measure was Permanent Product Measure of Performance-Total (PERMP-T) score.

resultsOf 288 subjects enrolled, 221 completed the ALC visit. PERMP-T score was significantly higher for PRC-063 versus placebo at every assessment from 1 to 16 hours post-dose at the ALC visit and when averaged over 16 hours post-dose (least-squares mean difference 16.3, 95% confidence interval 7.6-24.9). The most frequent adverse events during dose optimization were headache, decreased appetite, and insomnia.

conclusionPRC-063 provided rapid and sustained symptom relief in adults with ADHD and was well tolerated. NCT03618030.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsMethylphenidateAdultDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodHumansTreatment OutcomeCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateadult ADHDALC environmentefficacymethylphenidatesafetysustained and long-lasting stimulant

Identifiers

PMID34189995
PMCPMC8859679
OpenAlexW3173638585

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.