A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
- Conditions
- Narcolepsy Type 1
- Interventions
- Drug: TAK-861
- Registration Number
- NCT05816382
- Lead Sponsor
- Takeda
- Brief Summary
The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
- Detailed Description
The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This study will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.
This study was initiated in parallel with the parent phase 2 studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) study enrolled participants with both diagnoses from the two phase 2 studies. As the TAK-861-2002 study did not meet prespecified criteria, all participants with NT2 have been discontinued, and this extension study will only include participants with NT1 who previously completed a parent study. Additional parent studies include all TAK-861 phase 3 studies.
The study will enroll up to 500 patients. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861.
Participants with NT1 will receive the following dose from the parent study:
* TAK-861 Dose 1
* TAK-861 Dose 2
This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to approximately 5 years. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health) and will have a follow-up assessment 4 weeks after the last dose of study drug.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAK-861 Dose 1 TAK-861 Participants will receive TAK-861 dose 1 for up to approximately 5 years. TAK-861 Dose 2 TAK-861 Participants will receive TAK-861 dose 2 for up to approximately 5 years.
- Primary Outcome Measures
Name Time Method Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years) An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
- Secondary Outcome Measures
Name Time Method Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT) Baseline (parent study), Week 26 (current LTE study) The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score Baseline (parent study); Week 2 through Year 5 (current LTE study) The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary Baseline (parent study); Year 1 through Year 5 (current LTE study) Participants will record episodes of cataplexy in the diary throughout the study.
Trial Locations
- Locations (52)
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
🇩🇪Schwerin, Mecklenburg-Vorpommern, Germany
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
University of Oslo
🇳🇴Oslo, Norway
Klinik Barmelweid AG
🇨🇭Barmelweid, Aargau (de), Switzerland
Universitaetsspital Bern - Inselspital
🇨🇭Bern, Switzerland
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
Neurotrials Research
🇺🇸Atlanta, Georgia, United States
Bogan Sleep Consultants, LLC
🇺🇸Columbia, South Carolina, United States
Stanford Center for Sleep Sciences and Medicine
🇺🇸Redwood City, California, United States
Hopital Pierre-Paul Riquet
🇫🇷Toulouse, Haute-Garonne, France
CHU de Grenoble
🇫🇷La Tronche, Isere, France
Hospital Vithas Madrid Arturo Soria
🇪🇸Madrid, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Koishikawa Tokyo Hospital
🇯🇵Bunkyo-Ku, Tokyo, Japan
Instituto de Investigaciones del Sueno
🇪🇸Madrid, Spain
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
Terveystalo Helsinki Sleep Clinic
🇫🇮Helsinki, Uusimaa, Finland
Howakai Kuwamizu Hospital
🇯🇵Kumamoto-Shi, Kumamoto, Japan
Gokeikai Osaka Kaisei Hospital
🇯🇵Osaka-Shi, Osaka, Japan
Ospedale Bellaria
🇮🇹Bellaria, Italy
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Universitaet Regensburg am Bezirksklinikum
🇩🇪Regensburg, Bayern, Germany
Neurocenter of Southern Switzerland
🇨🇭Lugano, Ticino (it), Switzerland
Woolcock Institute of Medical Research
🇦🇺Glebe, New South Wales, Australia
Klinische Forschung Hamburg
🇩🇪Hamburg, Germany
YOU ARIYOSHI Sleep Clinic
🇯🇵Nagasaki-Shi, Nagasaki, Japan
Hospital General de Castello
🇪🇸Castellón De La Plana, Castellon, Spain
CHU Gui De Chauliac
🇫🇷Montpellier, Herault, France
Hospital de La Ribera
🇪🇸Alzira, Valencia, Spain
Istituto Neurologico Mediterraneo Neuromed
🇮🇹Pozzilli, Molise, Italy
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
CTI Research Center
🇺🇸Cincinnati, Ohio, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Sleep Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Hopital de la Pitie Salpetriere
🇫🇷Paris, France
Delta Waves LLC - Hunt - PPDS
🇺🇸Colorado Springs, Colorado, United States
Georgia Neuro Center
🇺🇸Gainesville, Georgia, United States
Neurocare Inc
🇺🇸Newton, Massachusetts, United States
ARSM Research, LLC
🇺🇸Huntersville, North Carolina, United States
Charite - Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Kempenhaeghe - PPDS
🇳🇱Heeze, Noord-Brabant, Netherlands
Kurume University Hospital
🇯🇵Kurume-Shi, Hukuoka, Japan
Slaap-Waakcentrum SEIN Heemstede
🇳🇱Heemstede, Noord-Holland, Netherlands
Aichi Medical University Hospital
🇯🇵Nagakute, Japan
Hospital Universitario Araba Santiago
🇪🇸Vitoria, Alava, Spain
Sahlgrenska University Hospital
🇸🇪Goteborg, Vastra Gotalands Lan, Sweden
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Henry Ford Medical Center - Columbus
🇺🇸Novi, Michigan, United States
Research Carolina Elite
🇺🇸Denver, North Carolina, United States
Children's Specialty Group
🇺🇸Norfolk, Virginia, United States
Florida Pediatric Research Institute
🇺🇸Orlando, Florida, United States
Medical University of South Carolina - PPDS
🇺🇸Charleston, South Carolina, United States