Trial · NCT02978651
Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness
NCT02978651, Phase 3, Withdrawn, Bioprojet
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness. Trials, record NCT02978651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02978651
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness
- NCT number
- NCT02978651
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Bioprojet
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea
- Interventions
- Pitolisant (BF2.649), Placebo Oral Tablet
- First posted
- 2016-12-01
- Last updated
- 2017-11-24
- Other registries' IDs
- eudract:2016-002963-32
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Epworth sleepiness scale (ESS) | Change from Baseline of ESS at 12 weeks and Change from Baseline of ESS at 52 weeks | |
| Secondary | Percentage of ESS responders | at week 12 /52 versus baseline | |
| Secondary | Reduction of sleepiness and sleep episodes on the sleep diary | at week 12 /52 versus baseline | |
| Secondary | Improvement in vigilance according to Oxford Sleep Resistance (OSleR) test | at week 12 /52 versus baseline | |
| Secondary | European Quality of Life Questionnaire (EQ-5D) | at week 12 /52 versus baseline | |
| Secondary | Leeds Sleep Evaluation Questionnaire (LSEQ) | at week 12 /52 versus baseline | |
| Secondary | The Pichot Fatigue Scale | at week 12 /52 versus baseline | |
| Secondary | Trail Making Test parts (A and B) | at week 12 /52 versus baseline | |
| Secondary | Improvement in Clinical Global Impression (CGI) | at week 12 /52 versus baseline | |
| Secondary | Z-score: composite score including ESS and OSLER results | at week 12 /52 versus baseline |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02978651
GET https://conductscience.org/api/trials/v1/NCT02978651/registered