Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Cataplexy

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    27 result(s) found for: Cataplexy. Displaying page 1 of 2.
    1  2  Next»
    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: 2014-001389-93 Sponsor Protocol Number: 13-005 Start Date*: 2015-08-27
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Su...
    Medical condition: Narcolepsy with Cataplexy
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005035-41 Sponsor Protocol Number: THN102-201 Start Date*: 2018-05-29
    Sponsor Name:Theranexus SA
    Full Title: SAFETY AND EFFICACY OF THN102 ON SLEEPINESS IN NARCOLEPTIC PATIENTS
    Medical condition: This Proof-of-Concept, Phase IIa trial with THN102 should collect a sufficient body of information to assess efficacy and safety profile of THN102 versus modafinil alone in patient with a diagnosis...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    20.0 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    20.0 10029205 - Nervous system disorders 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000426-20 Sponsor Protocol Number: 15-006 Start Date*: 2016-09-05
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy
    Medical condition: Treatment of cataplexy in narcolepsy Treatment of excessive daytime sleepiness (EDS) in narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10015595 Excessive daytime sleepiness LLT
    20.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DE (Completed) ES (Completed) FR (Completed) BE (Completed) FI (Completed) HR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-011302-41 Sponsor Protocol Number: CHUBX2008/37 Start Date*: 2009-05-15
    Sponsor Name:CHU de Bordeaux
    Full Title: METHODE D’EVALUATION DE L’APTITUDE A LA CONDUITE CHEZ DES PATIENTS SOUFFRANT DE PATHOLOGIES DE L’EVEIL AutoSoP
    Medical condition: Narcoleptic patients with cataplexy or hypersomniacs
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028715 Narcolepsy with cataplexy LLT
    9.1 10020765 Hypersomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: View results
    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: 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: 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: 2016-000359-29 Sponsor Protocol Number: CLFT218-1501 Start Date*: 2016-11-09
    Sponsor Name:Flamel Ireland Limited (trading under the business name Avadel Ireland)
    Full Title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT...
    Medical condition: The treatment of cataplexy and excessive daytime sleepiness on narcolepsy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DK (Prematurely Ended) DE (Completed) GB (Completed) FI (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004342-28 Sponsor Protocol Number: PKFT218-1602 Start Date*: 2017-10-30
    Sponsor Name:Flamel Ireland Ltd trading under the business name Avadel Ireland
    Full Title: A comparative, open label, randomized, 2 periods, 2 sequence crossover study to assess the relative bioavailability of sodium oxybate for extended release oral suspension (FT218) formulation (singl...
    Medical condition: A trial on healthy volunteer fore the development of a treatment for cataplexy and excessive daytime sleepiness in narcolepsy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007845-29 Sponsor Protocol Number: P07-07 / BF 2.649 Start Date*: Information not available in EudraCT
    Sponsor Name:Bioprojet
    Full Title: Prospective, randomized, double-blind study, parallel-group, multi-center trial assessing the effects of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narco...
    Medical condition: Cataplexy in patients with narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028713 Narcolepsy LLT
    9.1 10048322 Narcolepsy aggravated LLT
    9.1 10021235 Idiopathic narcolepsy LLT
    9.1 10007737 Cataplexy LLT
    9.1 10048323 Cataplexy aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-004417-15 Sponsor Protocol Number: DEV/ASP/00645.2006 Start Date*: 2006-04-18
    Sponsor Name:UCB Pharma Ltd
    Full Title: Single center, therapeutic exploratory clinical trial to evaluate the safety of sodium oxybate (Xyrem) 500 mg/mL oral solution on potential endocrine changes at currently labeled therapeutic dose r...
    Medical condition: Cataplexy in adult patients with narcolepsy
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002965-13 Sponsor Protocol Number: TAK-861-2003 Start Date*: 2023-04-11
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
    Medical condition: Narcolepsy with Cataplexy (Type 1) and Narcolepsy without Cataplexy (Type 2)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) IT (Trial now transitioned) ES (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) SE (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001654-38 Sponsor Protocol Number: TAK-861-2001 Start Date*: 2023-05-26
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
    Medical condition: Narcolepsy with cataplexy (Narcolepsy Type 1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NO (Completed) FI (Completed) SE (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-007866-46 Sponsor Protocol Number: P07-03 / BF 2.649 Start Date*: Information not available in EudraCT
    Sponsor Name:Bioprojet
    Full Title: 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 (HARM...
    Medical condition: Narcolepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028713 Narcolepsy LLT
    9.1 10048322 Narcolepsy aggravated LLT
    9.1 10021235 Idiopathic narcolepsy LLT
    9.1 10007737 Cataplexy LLT
    9.1 10048323 Cataplexy aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-000777-24 Sponsor Protocol Number: TAK-994-1501 Start Date*: 2021-05-17
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy W...
    Medical condition: Narcolepsy With or Without Cataplexy
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) FR (Prematurely Ended) CZ (Completed) NL (Prematurely Ended) FI (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003671-19 Sponsor Protocol Number: 71534 Start Date*: 2020-01-13
    Sponsor Name:Stichting Epilepsie Instellingen Nederland
    Full Title: Efficacy and safety of hydralazine in combination with valproate to treat hypocretin deficiency in recent onset narcolepsy: a pilot study
    Medical condition: Narcolepsy type 1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002966-34 Sponsor Protocol Number: TAK-861-2002 Start Date*: 2023-03-20
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)
    Medical condition: Narcolepsy without Cataplexy (Type 2)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) FR (Completed) IT (Completed) ES (Completed) FI (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: 2018-001584-23 Sponsor Protocol Number: 7605 Start Date*: 2018-10-30
    Sponsor Name:University Hospital of Montpellier
    Full Title: "Microglial Activation in Narcolepsy Type 1: Positron Emission Tomography (PET) Study in [18F] DPA-714"
    Medical condition: To study in vivo microglial activation by PET [18F] DPA-714 in NT1 patients with recent evolution (appearance of the first symptoms - somnolence and cataplexy-less than 2 years ago) compared with c...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 29 21:08:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA