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Clinical trials for Pitolisant

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    14 result(s) found for: Pitolisant. Displaying page 1 of 1.
    EudraCT Number: 2013-001506-29 Sponsor Protocol Number: P11-06/BF2.649 Start Date*: 2016-06-14
    Sponsor Name:Bioprojet
    Full Title: DOUBLE BLIND, MULTICENTRE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE SAFETY AND EFFICACY OF PITOLISANT IN CHILDREN FROM 6 TO LESS THAN 18 YEARS WITH NARCOLEPSY WITH/WITHOUT CATAPLEXY, FOLLOW...
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    20.0 10029205 - Nervous system disorders 10048322 Narcolepsy aggravated LLT
    20.0 10029205 - Nervous system disorders 10007737 Cataplexy PT
    20.0 10029205 - Nervous system disorders 10048323 Cataplexy aggravated LLT
    20.0 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) FR (Trial now transitioned) DE (Prematurely Ended) NL (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-017248-14 Sponsor Protocol Number: P09-08/BF2.649–HAROSAI Start Date*: 2011-02-21
    Sponsor Name:BIOPROJET
    Full Title: BF2.649 in patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS).
    Medical condition: Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FI (Completed) SE (Completed) DK (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-017251-94 Sponsor Protocol Number: P09-09/BF2.649 Start Date*: 2011-02-21
    Sponsor Name:Bioprojet
    Full Title: Efficacy and safety of BF2.649 in the treatment of Excessive Daytime Sleepiness in patients with Obstructive Sleep Apnoea syndrome (OSA), refusing the nasal continuous positive airway pressure (nCP...
    Medical condition: Excessive diurnal sleepiness in patients with moderate to severe Obstructive Sleep Apnoea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FI (Completed) SE (Completed) DK (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-004561-85 Sponsor Protocol Number: P1513/BF2.649 Start Date*: 2016-02-24
    Sponsor Name:Bioprojet Pharma
    Full Title: Efficacy and Safety of Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway P...
    Medical condition: Patients with Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, but Still Complaining of Excessive Daytime Sleepiness (EDS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-003076-39 Sponsor Protocol Number: P11-05 Start Date*: 2012-10-10
    Sponsor Name:Bioprojet
    Full Title: A randomized, double blind study comparing BF2.649 (Pitolisant) to placebo in two parallel groups on the weekly frequency of cataplexy attacks and Excessive Daytime Sleepiness in narcoleptic patien...
    Medical condition: Narcolepsy with Cataplexy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-000207-90 Sponsor Protocol Number: P15-14/BF2.649 Start Date*: 2016-11-24
    Sponsor Name:BIPROJET PHARMA
    Full Title: A Multisite Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Pitolisant (BF2.649) For Alcohol Use Disorder Treatment.
    Medical condition: Patients with moderate to severe alcohol use disorder
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10001584 Alcohol abuse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001505-93 Sponsor Protocol Number: P11-11 Start Date*: 2013-12-19
    Sponsor Name:Bioprojet Pharma
    Full Title: A MULTI-CENTRE, SINGLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS OF PITOLISANT (BF2.649) IN CHILDREN FROM 6 TO LESS THAN 18 YEARS WITH NARCOLEPSY
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-013886-24 Sponsor Protocol Number: P06-11 / BF2.649 Start Date*: 2010-03-03
    Sponsor Name:BIOPROJET
    Full Title: A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease
    Medical condition: Excessive daytime sleepiness in Parkinson’s Disease
    Disease: Version SOC Term Classification Code Term Level
    12.0 10015595 Excessive daytime sleepiness LLT
    12.0 10034005 Parkinson's disease and parkinsonism HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023804-28 Sponsor Protocol Number: P09-10/ BF2.649 Start Date*: 2011-07-29
    Sponsor Name:Bioprojet
    Full Title: An open-label naturalistic pragmatic study to assess the long term safety of BF2.649 (Pitolisant) in the treatment of Excessive Daytime Sleepiness (EDS) in narcolepsy (12 months follow-up).
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    13.1 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    13.1 10029205 - Nervous system disorders 10048323 Cataplexy aggravated LLT
    13.1 10029205 - Nervous system disorders 10007737 Cataplexy PT
    13.1 10029205 - Nervous system disorders 10048322 Narcolepsy aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-000084-27 Sponsor Protocol Number: P10-01/BF2.649 Start Date*: 2012-07-06
    Sponsor Name:Bioprojet
    Full 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...
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029205 - Nervous system disorders 10048322 Narcolepsy aggravated LLT
    15.1 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    15.1 10029205 - Nervous system disorders 10007737 Cataplexy PT
    15.1 10029205 - Nervous system disorders 10048323 Cataplexy aggravated LLT
    15.1 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2009-013885-14 Sponsor Protocol Number: P06-10/BF2.649 Start Date*: 2009-11-12
    Sponsor Name:BIOPROJET
    Full Title: A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week ope...
    Medical condition: Excessive daytime sleepiness in Parkinson?s Disease Somnolencia diurna excesiva en la enfermedad de Parkinson.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10015595 Excessive daytime sleepiness LLT
    12.0 10034005 Parkinson's disease and parkinsonism HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019687-36 Sponsor Protocol Number: P09-15/BF2.649 Start Date*: 2010-07-15
    Sponsor Name:Bioprojet
    Full Title: Randomized, double-blind, placebo and comparator-controlled, parallel-group, multi-center trial assessing the effects of BF2.649 in the treatment of excessive daytime sleepiness in narcolepsy
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    12.1 10028713 Narcolepsy LLT
    12.1 10048322 Narcolepsy aggravated LLT
    12.1 10021235 Idiopathic narcolepsy LLT
    12.1 10007737 Cataplexy LLT
    12.1 10048323 Cataplexy aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) FI (Completed) HU (Completed) IT (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019413-25 Sponsor Protocol Number: P09-16/BF2.649 Start Date*: 2010-06-28
    Sponsor Name:Bioprojet
    Full Title: Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patie...
    Medical condition: Treatment of excessive daytime sleepiness associated to obstructive sleep apnea
    Disease: Version SOC Term Classification Code Term Level
    12.1 10055577 Obstructive sleep apnea syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003008-11 Sponsor Protocol Number: JZP865-101 Start Date*: 2020-08-31
    Sponsor Name:Jazz Pharmaceuticals, Inc.
    Full Title: An Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects with Narcolepsy
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10021235 Idiopathic narcolepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) NL (Ongoing) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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