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CompletedNCT01067222Harmony1Updated Jun 11, 2012

Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

A Phase 3 interventional study of BF2.649 and Modafinil in Narcolepsy, Excessive Daytime Sleepiness and Cataplexy, sponsored by Bioprojet. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-11.

Primary conditionCataplexyRegistry: NarcolepsyReclassifiedWhy we changed it
Registry
Narcolepsy — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cataplexy
Why
  1. The study's listed conditions name Cataplexy, a narrower term within Narcolepsy.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Bioprojet · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Read the detailed description

BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.

The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

60 patients with narcolepsy with or without cataplexy will be included.

02

Conditions studied

  • Narcolepsy
  • Excessive Daytime Sleepiness
  • Cataplexy
  • Sleep Disorders

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Keywords

  • Narcolepsy
  • Excessive daytime Sleepiness
  • Cataplexy
  • Sleep Disorders
  • Sleep attacks
  • Orphan Drug
  • Pitolisant
03

In context

Cataplexy Reclassified

31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.

This study's enrollment of 110 is close to the median of 117 across 27 interventional studies indexed under Cataplexy.

Browse Cataplexy studies →

Lead sponsor

Bioprojet is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of narcolepsy with or without cataplexy
  • patients need to free of or discontinue psychostimulant medications for at least 14 days,
  • patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
  • patients must have adequate support to comply with the entire study requirements

Exclusion criteria

Exclusion Criteria:

  • Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
  • Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
  • Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
  • Current or recent history of a substance abuse or dependence disorder including alcohol abuse
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    BF2.649

    Drug: BF2.649

  • Active comparator
    Modafinil

    Drug: Modafinil

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBF2.649

    BF2.649 oral capsules at 10 or 20 or 40 mg per day

    Also known as: Pitolisant

  • DrugModafinil

    Modafinil oral capsules at 100 or 200 or 400 mg per day

    Also known as: Modiodal

  • DrugPlacebo

    Placebo oral capsules, 4 capsules per day

06

What researchers measure

Primary outcomes

  1. Epworth Sleepiness Scale (ESS)

    Time frame: between baseline and at the end of 8 week DB phase

Secondary outcomes

  1. Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks

    Time frame: 14 days before randomization and 7 days before each visit

  2. Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).

    Time frame: at inclusion and after 8-week treatment

07

Study locations

1 site
  • Neurocenter (EOC) of Southern Switzerland
    Lugano, 6903, Switzerland
08

References and documents

Publications

  • Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21. PubMed 34935103 ↗
  • Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25. PubMed 34822113 ↗
  • Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7. PubMed 24107292 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of Jul 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2010
First posted
Feb 11, 2010
Start
May 2009
Primary completionActual
Jul 2010
CompletionActual
Dec 2010
Last update
Jun 11, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01067222
Lead sponsor
Bioprojet
Responsible party
Sponsor
First posted
Feb 11, 2010
Start date
May 2009
Primary completion
Jul 2010
Completion
Dec 2010
Last update
Jun 11, 2012

Study contacts

Claudio Bassetti
principal investigator · Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pitolisant

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