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

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

Nonomura Hidenori

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

smb.Japanclinicalstudydisclosure@takeda.com

Contact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

+81-6-6204-2111

smb.Japanclinicalstudydisclosure@takeda.com

Recruiting

April. 05, 2023

Interventional

single arm study

open(masking not used)

dose comparison control

single assignment

treatment purpose

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.

1. 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.
2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
6. Participant has developed (within the last 6 months) gastrointestinal
disease that is expected to influence the absorption of drugs.
7. Participant has epilepsy or history of seizure.
8. 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.
9. Participant has a history of cerebral ischemia, transient ischemic attack (less than (<) 5 years ago), or cerebral hemorrhage.
10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
11. Participant has a history of cancer in the past 5 years.

Both

Narcolepsy Type 1

TAK-861:
In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed.

1. 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)
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 trial intervention.

1. 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 long-term extension [LTE] trial)
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.

2. 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)
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.

3. 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)
Participants will record episodes of cataplexy in the diary throughout the trial.

+81-3-5773-5570

April. 04, 2023

Yes

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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