- Trials with a EudraCT protocol (26)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
26 result(s) found for: Nervous System Diseases AND Narcolepsy.
Displaying page 1 of 2.
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... | |||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: BE (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 | |||||||||||||
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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: 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 | |||||||||||||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||||||||||||
Trial protocol: HU (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 | ||||||||||||||||||
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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: 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 | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Ongoing) | |||||||||||||
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 | |||||||||||||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||||||||||||
Trial protocol: DE (Completed) ES (Completed) FI (Completed) | |||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||||
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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: 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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Completed) BG (Completed) CZ (Completed) | |||||||||||||
Trial results: View results |
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) | |||||||||||||
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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: 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) | |||||||||||||
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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) | |||||||||||||
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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: 2021-000251-39 | Sponsor Protocol Number: TAK-994-1504 | Start Date*: 2021-08-12 | |||||||||||
Sponsor Name:Takeda Development Center Americas, Inc. | |||||||||||||
Full Title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults Wi... | |||||||||||||
Medical condition: Narcolepsy With Cataplexy | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: CZ (Completed) HU (Completed) FR (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2013-002545-10 | Sponsor Protocol Number: OSU6162Open1309 | Start Date*: 2014-01-08 |
Sponsor Name:A. Carlsson Research AB | ||
Full Title: An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g P... | ||
Medical condition: Parkinsons disease Huntingtons disease Multiple scleros Brain trauma Stroke Myalgic encephalomyelitis Narcolepsy | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: SE (Completed) | ||
Trial results: (No results available) |
EudraCT Number: 2006-002088-18 | Sponsor Protocol Number: H3A106104 | Start Date*: 2006-10-12 | |||||||||||
Sponsor Name:GlaxoSmithKline Research & Development Ltd | |||||||||||||
Full Title: An open label, dose escalation study with a double blind randomised placebo controlled withdrawal to examine the effects of the histamine H3 antagonist GSK189254 in patients with narcolepsy. | |||||||||||||
Medical condition: Narcolepsy | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) NL (Prematurely Ended) AT (Completed) FI (Prematurely Ended) ES (Completed) | |||||||||||||
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 | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) FR (Ongoing) | |||||||||||||
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 | |||||||||||||||||||||||||||||||||
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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: 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 | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) FR (Completed) NL (Ongoing) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-003931-36 | Sponsor Protocol Number: 15-005 | Start Date*: 2016-05-02 | |||||||||||
Sponsor Name:Jazz Pharmaceuticals Inc. | |||||||||||||
Full Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Narcolepsy | |||||||||||||
Medical condition: Treatment of excessive sleepiness in adult patients with narcolepsy | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Completed) DE (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: 2014-005487-15 | Sponsor Protocol Number: 14-002 | Start Date*: 2015-08-17 | |||||||||||
Sponsor Name:Jazz Pharmaceuticals Inc. | |||||||||||||
Full Title: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treat... | |||||||||||||
Medical condition: Treatment of excessive sleepiness in adult patients with narcolepsy | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) FI (Completed) NL (Completed) FR (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
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