Trial · NCT01638403
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
NCT01638403, Phase 3, Completed, Bioprojet
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. Trials, record NCT01638403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01638403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
- NCT number
- NCT01638403
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 180 participants, actual
- Lead sponsor
- Bioprojet
- Conditions
- Treatment of Excessive Daytime Sleepiness in Narcolepsy
- Interventions
- BF2.649, Vigil, palcebo
- First posted
- 2012-07-11
- Last updated
- 2017-01-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Epworth Sleepiness Scale scores (ESS) | 10 weeks | The primary efficacy endpoint is Epworth Sleepiness Scale scores (ESS) change between the BF2.649-treatment group, the placebo-group, and the Modafinil-treatment group during an 8-week treatment period. The ESS is a self-administered questionnaire to the patients to evaluate their chances of dozing in height different situations often encountered in the daily life. The average of ESS performed at V6 and V7 will be compared to the average of ESS performed at V2 and V3. |
| Secondary | patient sleep diary | 10 weeks | Following secondary outcome measures will be reported in the patient sleep diary: 1. Number and duration of diurnal involuntary sleep attacks and episodes of severe sleepiness 2. Number of cataplexy total and partial. 3. Number of hallucinations. 4. Number of sleep paralysis. 5. Number and duration of nocturnal awakening and total duration of nocturnal sleep time. |
| Secondary | Maintenance of Wakefulness Test (MWT) | 10 weeks | The Maintenance of Wakefulness Test (MWT) is used in this study to assess an individual's ability to maintain awake while resisting the pressure to fall asleep. Patients will be administrated four 40-minute MWT sessions at 2 hours interval at inclusion visit (V3) and at endpoint visit (V7 or the last on-study visit), according to validated standard \[Doghramji K et al, Electroencephalogr Clin Neurophysiol. 1997\] . The changes in MWT will be compared between the treatment groups. The MWT will be renewed at V7 only for patients who had a MWT \<11 at V3. |
| Secondary | Test of Sustained Attention to Response Task (SART) | 10 weeks | The Test of Sustained Attention to Response Task (SART) has been used for the quantification of vigilance and attention in narcolepsy patients \[Fronczek R et al, Sleep 2006\] . The SART will be performed at inclusion visit (V3) and at endpoint (V7 or the last on-study visit for prematurely withdrawn patients). The changes in SART will be compared between the treatment groups. |
| Secondary | Clinical Global Impressions of Change | 10 weeks | The severities of EDS and of cataplexy will be measured at baseline by the investigator using the Clinical Global Impression of Severity (CGI-S) in order to describe the population. At each follow-up visit, the patients' change in EDS and in cataplexy compared to baseline will be rated by the same investigator using Clinical Global Impression of Change (CGI-C) to document the perceived change in patients' illness. |
| Secondary | European Quality of life questionnaire (EQ-5D) | 10 weeks | EQ-5D is a reliable and validated measure of quality of life. Narcolepsy has a clear negative effect on this outcome measure \[Dodel R. et al, Sleep Med. 2007\] . EQ-5D will be completed at baseline visit (V2), inclusion visit (V3), stable-dose visit (V5), endpoint visit (V7) and withdrawal visit (V8). The changes between treatment groups will be analysed as an evaluation of the illness evolution. |
| Secondary | Patient's Global Opinion on the effect of treatment | 10 weeks | At each visit under treatment (V4, V5, V6, V7 and V8 or last on-study visit), patients evaluate the Global effect of their treatment by comparing the period prior to that visit with the patient's prestudy condition. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16494086 | BACKGROUND |
Source PubMed
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.
Tests1
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 |
|---|---|
| Sustained Attention to Response | Secondary outcome |
Source 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/NCT01638403
GET https://conductscience.org/api/trials/v1/NCT01638403/registered