Pitolisant 40 mg for excessive daytime sleepiness in obstructive sleep apnea patients treated or not by CPAP: Randomised phase 3 study

Assessed by RV012 · Lecturer (Teaching & Research)

Assessed on 30 Oct 2025

OverallReviewer's overall integrity assessment, derived from all research questions No concerns

DOI 10.1111/jsr.14373 (opens in new tab)

Resource ripekg:research-integrity-assessment/RIPEA44B073B6366CEDA7

5 Research Questions · 2 Evidence Items

Q1.1 — Does the study have an associated retraction?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: Checked the journal page and paper and did not find any notices

Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: Checked PubPeer as well and found nothing.

Q1.3 — Do other studies by the research team highlight causes for concern?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No concerns from me

Q2.2 — Are there concerns relating to the timing or absence of study registration?

Automated Assessment:Assessment produced by the automated systemYes

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: Registration was only a few days after recruitment started, and trial lasted a few years. Authors updated the records when study finished. Publication many years after the trial ended, but is this an issue?

Supporting Evidence (2)

Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)

Registration ID: NCT02739568

Registry: ClinicalTrials.gov

Registry Link: https://clinicaltrials.gov/study/NCT02739568 (opens in new tab)

Registration Date: 12-04-2016

Prospective:Whether the trial was registered before participant recruitment began No

Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates Registration date is after LLM recruitment start date.

Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text

Recruitment Start: 07-04-2016

Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Trial Registration Information: 'date of first patient dosed 7 April 2016'.

Recruitment End: 24-04-2019

Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date Results: 'between 7 April 2016 and 24 April 2019, to receive pitolisant (n = 242) or placebo (n = 119), which represented the FAS'.

Study End: N/A

Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date No explicit study end date found. The randomised phase ended at week 12.

Overall — What is the overall integrity assessment of the study?

Automated Assessment:Assessment produced by the automated systemN/A

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo concerns

Rationale: I would have no concerns based on what was assessed here.