Study on the Long-term Safety of TAK-861 for Patients with Narcolepsy Type 1

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What is this study about?

This clinical trial is focused on studying a condition known as Narcolepsy with Cataplexy, which is also referred to as Narcolepsy Type 1. Narcolepsy is a sleep disorder that causes excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. The study is evaluating a treatment called TAK-861, which is taken in tablet form. The purpose of the study is to assess the long-term safety and tolerability of this medication in individuals with this condition.

Participants in the study will take TAK-861 over a period of time to see how well they tolerate the medication and to monitor any side effects that may occur. The study aims to ensure that the medication is safe for long-term use. Participants will be monitored for any treatment-emergent adverse events, which are any unwanted effects that occur after starting the medication.

The study will also look at changes in sleep patterns and symptoms from the beginning of the study to the end. This includes measuring how long participants can stay awake during the day and tracking any changes in their cataplexy symptoms using a diary. The study is expected to continue until early 2028, providing valuable information on the long-term use of TAK-861 for managing Narcolepsy with Cataplexy.

1 joining the study

Participation begins after completing a previous controlled study with TAK-861.

Enrollment is contingent upon the absence of any clinical objections from the investigator.

2 medication administration

The medication TAK-861 is administered in the form of a tablet.

The route of administration is oral.

3 monitoring and evaluation

The primary focus is on the occurrence of any treatment-emergent adverse events.

Secondary evaluations include changes from baseline in sleep latency, total score on the Epworth Sleepiness Scale (ESS), and cataplexy occurrences as recorded in a diary.

4 duration of the study

The study is designed to continue until February 28, 2028.

The long-term goal is to assess the safety and tolerability of TAK-861 over an extended period.

Who Can Join the Study?

  • The participant must have a diagnosis of Narcolepsy with Cataplexy, also known as Narcolepsy Type 1. This is a sleep disorder that includes sudden muscle weakness.
  • The participant must have completed a previous controlled study with the medication TAK-861. This means they have already taken part in a study where the effects of the medication were closely monitored.
  • The study doctor must have no medical concerns about the participant joining this new study.
  • Participants can be of any gender, meaning both males and females are eligible.
  • The study is open to certain age groups, specifically those that fall into categories 3 and 4, which typically include children and adults.
  • The study does not include vulnerable populations, which generally refers to groups that might need special protection or care.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Linden Sp. z o.o. sp.k. Cracow Poland
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Centre Hospitalier Regional De La Citadelle Liege Belgium
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH Schwerin Germany
Hnumlxyf Vpfr dwxrxrgv Barcelona Spain
Awpvfcffdx Pkohrzqh Hgpcptvb Dc Mpecnlrqz Marseille France
Ujjgetk Uzbgrcjlel Hmzmborv Uppsala Sweden
Hgahxcrs Cxvezb Dd Brjkamqcc Barcelona Spain
Hedof Bbcasy Hj Bergen Norway
Cwamqx Hvojilhphpv Utuluhuzzixkh Dv Manvpksbrzd Montpellier France
Jeslknhl Kwjepz Ultnsnpjlm Linz Austria
Uffqshgzunjs Zodyfjbvzv Guhy Gent Belgium
Ckgscd Hwmlvrnecha Lbhz Srl Pierre Benite France
Hjdmfbvm Uczomrjaibpci Di Ls Rxoqpp Alzira Spain
Aqxaqom Uleiu Sffvtoupp Lnpdab Dd Bruzwlv Bologna Italy
Usysebuahhytqjfqjkppt Rqmwoyzixg Aem Regensburg Germany
Iowfgmql Nzhqrcanxxg Mwpkrblcnhcs Nlyehnie Ssoxaj Pozzilli Italy
Hlustewj Uxlprlphszbvi Asdfw Vitoria Spain
Htgxiyej Gvxlbuy Ulmtggaumjyub Dg Cmmvavsns Castello De La Plana Spain
Arepx Alken Belgium
Pafctbqwql himrjfcuvtarwbb Tampere Finland
Aobkrmey Skpht Rujnddax Gobv Berlin Germany
Eyolrsjtw Inupoqkyosvn Nyzavjlxv Slphgtgbb Zwolle The Netherlands
Pkbwkcucli Namur Belgium
Sklrtv Tvmiucoqtiz Oy Turku Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
26.02.2023
Belgium Belgium
Not recruiting
26.02.2023
Finland Finland
Not recruiting
26.02.2023
France France
Recruiting
26.02.2023
Germany Germany
Recruiting
26.02.2023
Italy Italy
Recruiting
26.02.2023
Norway Norway
Not recruiting
26.02.2023
Poland Poland
Not recruiting
26.02.2023
Spain Spain
Recruiting
26.02.2023
Sweden Sweden
Not recruiting
26.02.2023
The Netherlands The Netherlands
Recruiting
26.02.2023

Trial locations

TAK-861 is a medication being studied for its safety and tolerability in people with certain sleep disorders known as central hypersomnia conditions. The trial aims to understand how well patients can tolerate this medication over a long period and to ensure it is safe for use in managing these sleep conditions.

Narcolepsy with Cataplexy (Narcolepsy Type 1) – This is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. People with this condition often experience cataplexy, which is a sudden loss of muscle tone triggered by strong emotions such as laughter or surprise. The disorder disrupts the normal sleep-wake cycle, leading to fragmented nighttime sleep and excessive daytime sleepiness. Individuals may also experience sleep paralysis and hallucinations as they fall asleep or wake up. The condition is believed to be related to a deficiency of a brain chemical called hypocretin, which helps regulate wakefulness. Symptoms typically begin in childhood or adolescence and can significantly impact daily activities and quality of life.

Trial ID:
2023-508462-15-00
Protocol code:
TAK-861-2003
NCT ID:
NCT05816382
Trial Phase:
Therapeutic use (Phase IV)

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