Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)

June 8, 2012 updated by: Bioprojet

Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo oral capsules, 4 capsules per day
EXPERIMENTAL: BF2.649
Drug: BF2.649
BF2.649 oral capsules at 10 or 20 or 40 mg per day
Other Names:
  • Pitolisant
ACTIVE_COMPARATOR: Modafinil
Drug: Modafinil
Modafinil oral capsules at 100 or 200 or 400 mg per day
Other Names:
  • Modiodal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: between baseline and at the end of 8 week DB phase
between baseline and at the end of 8 week DB phase

Secondary Outcome Measures

Outcome Measure
Time Frame
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
14 days before randomization and 7 days before each visit
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Time Frame: at inclusion and after 8-week treatment
at inclusion and after 8-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioprojet

Investigators

  • Principal Investigator: Claudio Bassetti, Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (ESTIMATE)

February 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P07-03 / BF2.649
  • 2008-007866-46 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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