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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01789398
First received: February 8, 2013
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Narcolepsy
Drug: BF2.649
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • Efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    based on the ESS score change from baseline to final visit.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF2.649 (pitolisant)
Placebo of BF2.649 (5mg, 10mg, 20mg or 40mg) in capsules
Drug: BF2.649
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).
Other Name: pitolisant
Placebo Comparator: placebo
Placebo of BF2.649 (5mg, 10mg, 20mg or 40mg) in capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789398

Locations
France
CHU Montpellier
Montpellier, France, 34000
Sponsors and Collaborators
Bioprojet
Investigators
Study Chair: Yves DAUVILLIERS Hôpital Gui de Chauliac - 80, avenue A. Fliche , 34295 Montpellier cedex 5 - FRANCE
  More Information

No publications provided

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01789398     History of Changes
Other Study ID Numbers: P10-01 / BF2.649, 2011-000084-27
Study First Received: February 8, 2013
Last Updated: September 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014