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Clinical trials for Armodafinil

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    9 result(s) found for: Armodafinil. Displaying page 1 of 1.
    EudraCT Number: 2012-005510-20 Sponsor Protocol Number: C10953/1100 Start Date*: 2013-03-07
    Sponsor Name:Cephalon, Inc.
    Full Title: A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/day) in Children and Adolescents w...
    Medical condition: Excessive Sleepiness associated with Narcolepsy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-007555-14 Sponsor Protocol Number: C10953/2032/DP/US Start Date*: 2008-08-15
    Sponsor Name:Cephalon, Inc.
    Full Title: An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major ...
    Medical condition: Major Depression Associated With Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057840 Major depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-023623-26 Sponsor Protocol Number: C10953/3073 Start Date*: 2011-07-14
    Sponsor Name:Cephalon, Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major Depressio...
    Medical condition: Major Depression Associated With Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10004911 Bipolar affective disorder, depressed LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) FI (Completed) DE (Completed) IT (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-014545-83 Sponsor Protocol Number: C10953/3067/ES/MN Start Date*: 2010-02-24
    Sponsor Name:Cephalon Inc.
    Full Title: A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients wi...
    Medical condition: Patients with excessive Sleepiness associated with mild or moderate closed Traumatic Brain Injury (TBI)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10060690 Traumatic brain injury LLT
    12.0 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) FR (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016648-38 Sponsor Protocol Number: C10953/3074 Start Date*: 2010-08-06
    Sponsor Name:Cephalon, Inc.
    Full Title: A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With ...
    Medical condition: Major Depression Associated With Bipolar I Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) BG (Prematurely Ended) ES (Completed) DE (Prematurely Ended) FI (Completed) SK (Prematurely Ended) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014544-11 Sponsor Protocol Number: C10953/3069/ES/MN Start Date*: 2010-05-21
    Sponsor Name:Cephalon Inc
    Full Title: Estudio abierto de 12 meses para la evaluación de la seguridad, la tolerabilidad y la eficacia de armodafinil (150 mg/día y 250 mg/día) como tratamiento para pacientes con somnolencia excesiva asoc...
    Medical condition: Pacientes con somnolencia excesiva asociada a un trauma craneo-cerebral no penetrante leve o moderado. Excessive sleepiness accociated with mild or moderate closed traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    12.0 10060690 Traumatic brain injury LLT
    12.0 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016667-11 Sponsor Protocol Number: C10953/3071 Start Date*: 2010-04-29
    Sponsor Name:Cephalon, Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/day) as Adjunctive Therapy in Adults With Major D...
    Medical condition: Major Depression Associated With Bipolar I Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) BG (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-016634-27 Sponsor Protocol Number: C10953/3072 Start Date*: 2010-06-03
    Sponsor Name:Cephalon, Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/day) as Adjunctive Therapy in Adults With Major D...
    Medical condition: Major Depression Associated With Bipolar I Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) BG (Completed) ES (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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