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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 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 16 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-05
Primary completion: 2028-02-28
Study completion finish: 2028-02-28
Study type
TREATMENT
Phase
PHASE2
PHASE3
Trial ID
NCT05816382
Intervention or treatment
DRUG: TAK-861
Conditions
- • Narcolepsy Type 1
Find a site
Closest Location:
Woolcock Institute of Medical Research
Research sites nearby
Select from list below to view details:
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
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 Dose 1
| DRUG: TAK-861
|
EXPERIMENTAL: TAK-861 Dose 2
| DRUG: TAK-861
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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) |
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