A study of TAK-861 in individuals with narcolepsy type 1
Descrizione riassuntiva dello studio
This is a double-blind study, meaning that neither the study participants nor the investigator knows which treatment each participant receives (TAK-861, in different doses or placebo). Placebo tablets, which contain no active ingredient, look exactly like the TAK-861 tablets. This ensures that participants do not know which treatment they are receiving. The use of a placebo is necessary to determine whether TAK-861 actually has an effect on the symptoms of participants with NT1. Participants will first be screened to ensure they meet the study participation criteria. Participants who meet the study criteria will then receive either TAK 861 or a placebo for 12 weeks. At the end of the study, participants will be invited to participate in an extension study in which all participants will receive TAK-861, allowing researchers to gather more information on the safety of the study treatment. Participants who choose not to participate in the extension study will be followed for 4 weeks after their last dose. What do the study visits include? Participants receive the investigational product or a placebo (a substance that resembles the investigational product but contains no active ingredients) and undergo various assessments and procedures as part of the study. Neither the participants nor the study staff know who receives the investigational product and who receives the placebo. Participants will have approximately 10 scheduled study visits over a period of 14 to 23 weeks. The duration of the study depends on the current narcolepsy medications (which must be discontinued before the study begins). At the end of the study, participants may have the opportunity to participate in a long-term extension study in which all participants receive the actual investigational product.
(BASEC)
Intervento studiato
Participants are randomly assigned to groups, similar to drawing a stick. Some receive the investigational treatment (TAK-861), others a placebo, which is a substance without medical effect, often referred to as a "sugar pill." The treatment (TAK-861 or placebo) is administered over a period of 12 weeks.
(BASEC)
Malattie studiate
Narcolepsy with cataplexy (Narcolepsy type 1)
(BASEC)
Study population: This study can include men and women who meet the following essential study criteria at the start of the study: ▪ They are 18 to 70 years old. ▪ They have been diagnosed with narcolepsy type 1. ▪ They must achieve the minimum score on the Epworth Sleepiness Scale. ▪ They must experience a minimum number of cataplexy attacks per week. ▪ They have tested positive for a specific group of genes that regulate the immune system, or they have a low orexin level in the cerebrospinal fluid. (BASEC)
Criteri di esclusione
Potential study participants cannot participate in the study if any of the following apply: • They have a condition (other than narcolepsy) that is associated with excessive daytime sleepiness. • They have had cancer within the last 5 years. • They have a history of certain brain disorders or a severe head injury. • They have a history of heart attack or certain other serious health issues. • They regularly go to sleep after midnight, work night shifts, or plan a trip during the study period that involves jet lag. (BASEC)
Luogo dello studio
Berna, Lugano, Altro
(BASEC)
Aargau
(BASEC)
Sponsor
Sponsor: TAKEDA Sponsor’s representative in Switzerland :PPD Switzerland GmbH c/o Dufour Treuhand AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Ramin Khatami
+41 62 857 21 11
ramin.khatami@clutterbarmelweid.chCenter for Sleep Research and Sleep Medicine, Barmelweid, 5017 Clinic, Barmelweid AG, Switzerland
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
24.07.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK 861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1) (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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