A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Participant with a diagnosis of NT1 who has completed a controlled study 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 study drug from the parent study or discontinued because of TEAEs in the parent study.
- 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) or aspartate aminotransferase (AST) values >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 (<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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2PHASE3
Study ID
NCT05816382
Intervention or treatment
DRUG: TAK-861
Conditions
- Narcolepsy Type 1
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Woolcock Institute of Medical Research
Select from list below to view details:
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
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Who is running the clinical trial?
Takeda
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: TAK-861
| Drug: TAK-861 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) | 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. | From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years) |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT) | 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. | Baseline (parent study), Week 26 (current LTE study) |
| Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score | 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. | Baseline (parent study); Week 2 through Year 5 (current LTE study) |
| Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary | Participants will record episodes of cataplexy in the diary throughout the study. | Baseline (parent study); Year 1 through Year 5 (current LTE study) |
References
Clinical Trials Gov: A Study of TAK-861 for the Treatment of Selected Central Hypersomnia ConditionsOther trials to consider
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