search
Back to results

Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) (HARMONY IV)

Primary Purpose

Narcolepsy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
BF2.649
Sponsored by
Bioprojet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females, aged 18 years old and over.
  • Patients with a diagnosis of narcolepsy according to the International Classification of Sleep Disorders (ICSD-2) criteria
  • Patients treated with sodium oxybate (Xyrem®) with a stable dosage for at least 2 months prior to the trial.
  • Patients complaining of residual EDS
  • Patient should be free of non authorized drugs or discontinue any psychostimulant medication at least 3 weeks before randomization (V2).
  • Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding patient.
  • In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, self rating scales, drug compliance, scheduled visits, etc).
  • Patient must have voluntarily expressed a willingness to participate in this study, signed and dated an informed consent prior to beginning this protocol required procedures.

Exclusion Criteria:

  • Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical severe depression (BDI ≥ 16) with suicidal risk (item G BDI > 0), or depression treated for less than 8 weeks, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms.
  • Patients working in an occupation requiring variable shift work or routine night shifts.
  • Patients with an untreated sleep apnea disorder (defined as an apnea index > 10/h or an apnea/hypopnea index>15/h) or who have any other cause of daytime sleepiness.
  • Use of hypnotics, tranquilizers, sedating antihistamines, psychostimulants for the treatment of EDS (amphetamine and amphetamine-like CNS stimulants, modafinil, methylphenidate or others), benzodiazepines, anticonvulsants or clonidine will not be accepted at least 3 weeks before randomization (V2) and during study.
  • Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
  • Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation.
  • Patient with a known history of long QTc syndrome (e.g. syncope or arythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc interval strictly higher than 450 ms (electrocardiogram Bazett's corrected).
  • Patients with Severe Hepatic Impairment or with Severe Renal Impairment, or with any other significant abnormality in the physical examination or clinical laboratory results.
  • Known hypersensitivity to the tested treatment including active substance and excipients.
  • Patients participating in an other study and the use of any investigational therapy within the 30 days prior to the entry in this study.
  • Patient without any medical care insurance

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BF2.649 (pitolisant)

placebo

Arm Description

BF2.649 (5mg, 10mg, 20mg or 40mg) in capsules

Placebo of BF2.649 (5mg, 10mg, 20mg or 40mg) in capsules

Outcomes

Primary Outcome Measures

Efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale)
based on the ESS score change from baseline to final visit.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2013
Last Updated
November 17, 2015
Sponsor
Bioprojet
search

1. Study Identification

Unique Protocol Identification Number
NCT01789398
Brief Title
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
Acronym
HARMONY IV
Official Title
Double Blind Randomized Study to Assess the Efficacy of BF2.649 Compared to Placebo in add-on to Sodium Oxybate in the Treatment of Narcoleptic Patients With Residual Excessive Daytime Sleepiness (EDS) During 8 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioprojet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BF2.649 (pitolisant)
Arm Type
Experimental
Arm Description
BF2.649 (5mg, 10mg, 20mg or 40mg) in capsules
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of BF2.649 (5mg, 10mg, 20mg or 40mg) in capsules
Intervention Type
Drug
Intervention Name(s)
BF2.649
Other Intervention Name(s)
pitolisant
Intervention Description
BF2.649 is provided in capsules. Patients should take 1 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast).
Primary Outcome Measure Information:
Title
Efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale)
Description
based on the ESS score change from baseline to final visit.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, aged 18 years old and over. Patients with a diagnosis of narcolepsy according to the International Classification of Sleep Disorders (ICSD-2) criteria Patients treated with sodium oxybate (Xyrem®) with a stable dosage for at least 2 months prior to the trial. Patients complaining of residual EDS Patient should be free of non authorized drugs or discontinue any psychostimulant medication at least 3 weeks before randomization (V2). Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding patient. In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, self rating scales, drug compliance, scheduled visits, etc). Patient must have voluntarily expressed a willingness to participate in this study, signed and dated an informed consent prior to beginning this protocol required procedures. Exclusion Criteria: Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical severe depression (BDI ≥ 16) with suicidal risk (item G BDI > 0), or depression treated for less than 8 weeks, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms. Patients working in an occupation requiring variable shift work or routine night shifts. Patients with an untreated sleep apnea disorder (defined as an apnea index > 10/h or an apnea/hypopnea index>15/h) or who have any other cause of daytime sleepiness. Use of hypnotics, tranquilizers, sedating antihistamines, psychostimulants for the treatment of EDS (amphetamine and amphetamine-like CNS stimulants, modafinil, methylphenidate or others), benzodiazepines, anticonvulsants or clonidine will not be accepted at least 3 weeks before randomization (V2) and during study. Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation. Patient with a known history of long QTc syndrome (e.g. syncope or arythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc interval strictly higher than 450 ms (electrocardiogram Bazett's corrected). Patients with Severe Hepatic Impairment or with Severe Renal Impairment, or with any other significant abnormality in the physical examination or clinical laboratory results. Known hypersensitivity to the tested treatment including active substance and excipients. Patients participating in an other study and the use of any investigational therapy within the 30 days prior to the entry in this study. Patient without any medical care insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves DAUVILLIERS
Organizational Affiliation
Hôpital Gui de Chauliac - 80, avenue A. Fliche , 34295 Montpellier cedex 5 - FRANCE
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)

We'll reach out to this number within 24 hrs