CompletedNCT01067235Harmony2Updated Feb 11, 2013

Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

A Phase 3 interventional study of BF2.649 and BF2.649 add on Modafinil in Narcolepsy, Cataplexy and Excessive Daytime Sleepiness, sponsored by Bioprojet. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-11.

Primary conditionCataplexyRegistry: NarcolepsyReclassifiedWhy we changed it

Registry

Narcolepsy — the first condition term the registry derived for this study.

ClinicalTrials.gg

Cataplexy

Why

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: 14
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy

Read the detailed description

BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.

The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

Conditions studied

Narcolepsy
Cataplexy
Excessive Daytime Sleepiness

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Keywords

Narcolespy
Cataplexy
Excesssive daytime Sleepiness
Sleep Disorders
Sleep attacks
Orphan Drug
Pitolisant

In context

Cataplexy Reclassified

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

This study's enrollment of 14 is below 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 →

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

"De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period

Exclusion criteria

Exclusion Criteria:

Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
Current or recent history of a substance abuse or dependence disorder including alcohol abuse
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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 14 participants (actual)

Study arms

Experimental
BF2.649 + Modafinil placebo
Drug: BF2.649
Experimental
BF2.649 + Modafinil
Drug: BF2.649 add on Modafinil

Interventions

DrugBF2.649
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
Also known as: Pitolisant
DrugBF2.649 add on Modafinil
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks
Also known as: Pitolisant, Modiodal

What researchers measure

Primary outcomes

Cataplexy attacks reported on sleep diary
Time frame: every days from screening visit (day-14) to final visit (day 56)

Secondary outcomes

Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,
Time frame: every days from screening visit (day-14) to final visit (day 56)
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Time frame: at inclusion and after 8-week treatment
Epworth Sleepiness Scale (ESS)
Time frame: at each visit

Study locations

1 site

Neurocenter (EOC) of Southern Switzerland
Lugano, 6903, Switzerland

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Jul 2010 and a completion of Jul 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: Oct 2009
Primary completionActual: Jul 2010
CompletionActual: Jul 2010
Last update: Feb 11, 2013

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 Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01067235
Lead sponsor: Bioprojet
Responsible party: Sponsor
First posted: Feb 11, 2010
Start date: Oct 2009
Primary completion: Jul 2010
Completion: Jul 2010
Last update: Feb 11, 2013

Study contacts

Claudio Bassetti

principal investigator · Neurocenter of Southern Switzerland,Lugano

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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Pitolisant

Other studies in this condition

Cataplexy →

Other studies from this sponsor

Bioprojet

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