A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Official title

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Overview

The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Detailed description

The drug being tested in this trial is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This trial 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 trial was initiated in parallel with the parent phase 2 trials, 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) trial enrolled participants with both diagnoses from the two phase 2 trials. As the TAK-861-2002 trial did not meet prespecified criteria, all participants with NT2 were discontinued, and moving forward this extension study only includes participants with NT1 who previously completed a parent trial. Parent trials include all TAK-861 phase 3 trials in addition to the phase 2 trial participants from TAK-861-2001.

The trial will enroll up to 500 participants. All participants in the trial will receive TAK-861. Participants who were previously on a placebo dose will be assigned to one of the TAK-861 doses randomly.

This multi-center trial will be conducted worldwide. Study period is approximately 5 years or until the study is stopped at the sponsor's discretion, or the product is approved and launched. 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 trial intervention.

Interventions

• Drug TAK-861
  TAK-861 tablets

Primary outcome measures

• Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) [Time frame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)]

Secondary outcome measures (3)

• Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT) [Time frame: Baseline (parent trial), Week 26 (current LTE trial)]
• Change from Baseline in the Parent Trial in Epworth Sleepiness Scale (ESS) Total Score [Time frame: Baseline (parent trial); Week 2 through Year 5 (current LTE trial)]
• Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary [Time frame: Baseline (parent trial); Year 1 through Year 5 (current LTE trial)]

Eligibility criteria

Inclusion criteria

1\. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.

Exclusion criteria

• Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
• Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
• Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
• Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
• Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
• Participant has epilepsy or history of seizure.
• Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
• Participant has a history of cerebral ischemia, transient ischemic attack (less than (<) 5 years ago), or cerebral hemorrhage.
• Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
• Participant has a history of cancer in the past 5 years.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 19 centers

• Sleep Disorders Center of Alabama — Birmingham
• Stanford Center for Sleep Sciences and Medicine — Redwood City
• SDS Clinical Trials, Inc. — Santa Ana
• Delta Waves LLC - Hunt - PPDS — Colorado Springs
• Florida Pediatric Research Institute — Orlando
• Neurotrials Research — Atlanta
• Georgia Neuro Center — Gainesville
• Neurocare Inc — Newton
• … and 11 more centers

Spain · 7 centers

• Hospital Universitario Araba Santiago — Vitoria-Gasteiz
• Hospital General de Castello — Castellon
• Hospital de La Ribera — Alzira
• Hospital Universitario Vall d'Hebron - PPDS — Barcelona
• Hospital Clinic de Barcelona — Barcelona
• Instituto de Investigaciones del Sueno — Madrid
• Hospital Vithas Madrid Arturo Soria — Madrid

Japan · 6 centers

• Kurume University Hospital — Kurume-Shi
• Howakai Kuwamizu Hospital — Kumamoto
• YOU ARIYOSHI Sleep Clinic — Nagasaki
• Gokeikai Osaka Kaisei Hospital — Osaka
• Koishikawa Tokyo Hospital — Bunkyo-Ku
• Aichi Medical University Hospital — Nagakute

France · 4 centers

• Hopital Pierre-Paul Riquet — Toulouse
• CHU Gui De Chauliac — Montpellier
• CHU de Grenoble — La Tronche
• Hopital de la Pitie Salpetriere — Paris

Germany · 4 centers

• Universitaet Regensburg am Bezirksklinikum — Regensburg
• Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH — Schwerin
• Charite - Universitatsmedizin Berlin — Berlin
• Klinische Forschung Hamburg — Hamburg

Italy · 3 centers

• Fondazione PTV Policlinico Tor Vergata — Rome
• Istituto Neurologico Mediterraneo Neuromed — Pozzilli
• Ospedale Bellaria — Bellaria

Switzerland · 3 centers

• Klinik Barmelweid AG — Barmelweid
• Neurocenter of Southern Switzerland — Lugano
• Universitaetsspital Bern - Inselspital — Bern

Netherlands · 2 centers

• Kempenhaeghe - PPDS — Heeze
• Slaap-Waakcentrum SEIN Heemstede — Heemstede

Australia · 1 center

• Woolcock Institute of Medical Research — Glebe

Finland · 1 center

• Terveystalo Helsinki Sleep Clinic — Helsinki

Norway · 1 center

• University of Oslo — Oslo

Sweden · 1 center

• Sahlgrenska University Hospital — Gothenburg

Identifiers

NCT: NCT05816382 · TAK-861-2003 · U1111-1283-1888 · jRCT2031230135 · 2023-508462-15-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗