Evidence map›Paper›PMID 34057707›Full record

Trial reportCNS drugs2021

Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension.

Margaret Danielle Weiss, Craig Surman, Atul Khullar, Ellie He, Marc Cataldo, Graeme Donnelly

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CNS drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
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.

NCT02139124 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adult ADHD Patients

TypeinterventionalSponsorRhodes Pharmaceuticals, L.P.Ran2014 to 2015Enrolled375ConditionsADHDArmsPlacebo, PRC-063 25 mg, PRC-063 45 mg, PRC-063 70 mg, PRC-063 100 mg
NCT02168127 phase3completednot on this map

A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD

TypeinterventionalSponsorRhodes Pharmaceuticals, L.P.Ran2014 to 2015Enrolled360ConditionsADHDArmsDrug: PRC-063, PRC-063
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Effectiveness of anFood science & nutrition · 2025
    Article
  3. Review
  4. Article
  5. Review
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

6 authors at 5 institutions in 2 countries.

Margaret Danielle WeissChild and Adolescent Psychiatry, Cambridge Health Alliance, Cambridge, MA, USA. margaret.weiss@icloud.com.ORCID http://orcid.org/0000-0001-8153-8213
Craig SurmanClinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.
Atul KhullarDepartment of Psychiatry, University of Alberta, Edmonton, AB, Canada.
Ellie HeImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, CT, USA.
Marc CataldoPurdue Pharma L.P, Stamford, CT, USA.
Graeme DonnellyPurdue Pharma (Canada), Pickering, ON, Canada.
Purdue Pharma (United States) · USCambridge Health Alliance · USMassachusetts General Hospital · USPurdue Pharma (Canada) · CAUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effects of stimulant treatment on sleep in adults with attention-deficit/hyperactivity disorder (ADHD) are complex and varied, with some individuals experiencing worsening of sleep but others experiencing improvement.

methodsData from previously reported trials of the clinical efficacy and safety of the long-acting methylphenidate formulation PRC-063 (Adhansia XR

resultsAt the end of double-blind treatment, PRC-063 (all doses combined; N = 297) showed no significant difference versus placebo (N = 78) in least squares mean change in global PSQI score from baseline (- 0.7 vs. - 1.3; P = 0.0972) or in scores for each of the seven subscales of the PSQI. For patients enrolled in the open-label extension (N = 184), mean ± standard deviation global PSQI score improved from 7.8 ± 3.55 at the end of double-blind treatment to 5.8 ± 3.11 at 1 month and 5.4 ± 3.21 at 6 months (P < 0.0001). A greater proportion of patients were good sleepers (global PSQI score ≤ 5) at the end of the open-label extension (57.3%) than at baseline (20.9%) or at the end of double-blind treatment (26.0%). In a logistic regression analysis, baseline global PSQI score (odds ratio 1.491; P < 0.0001), but not randomized study treatment (P = 0.1428), was a significant predictor of poor sleep (global PSQI score > 5) at the end of double-blind treatment. Adverse event rates for insomnia (15.8 vs. 3.8%) and initial insomnia (6.1 vs. 1.3%) during double-blind treatment were higher for PRC-063 (all doses combined) than for placebo. Two patients receiving PRC-063 in the double-blind study and one patient in the open-label study were withdrawn because of insomnia adverse events.

conclusionsOur findings indicate that, on average, PRC-063 had no significant impact on overall sleep quality in adults with ADHD. Although insomnia was observed as an adverse event, when sleep was measured over time as an outcome in its own right for patients receiving dose-optimized PRC-063 open-label, more patients showed improvement in sleep than deterioration. CLINICALTRIALS. GOV IDENTIFER: NCT02139124 and NCT02168127.

Indexed as

AdultAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMethylphenidateSleepSleep Initiation and Maintenance DisordersSleep QualityCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidate

Identifiers

PMID34057707
PMCPMC8219576
OpenAlexW3164200337

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.