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

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario De La Ribera Alzira Spain
Pneumocare Namur Belgium
Linden Sp. z o.o. sp.k. Cracow Poland
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH Schwerin Germany
Suomen Terveystalo Oy Helsinki Finland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Hospital Universitario Araba Vitoria Spain
Hospital General Universitario De Castellon Castello De La Plana Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Anima Alken Belgium
Pirkanmaan hyvinvointialue Tampere Finland
Advanced Sleep Research GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Epilepsie Instellingen Nederland Stichting Zwolle The Netherlands
Axsokil Uglug Slufbeabi Ldwpdy Dk Badrxyf Bologna Italy
Auspihhbee Patyypll Hnjunwwf Dw Mzwczhagd Marseille France
Ugyrljg Uszcrirxbe Hlrtxybj Uppsala Sweden
Hghwt Bqbniw Hb Bergen Norway
Jyvjtevs Kmhdfi Uwvnmpfpvm Linz Austria
Hcuoaxhf Vgiy dqpcaaif Barcelona Spain

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.

Investigated diseases:

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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