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

Phase 2

Recruiting

• 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.

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study Start: 2023-04-05
• Study First Posted: 2023-04-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

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)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Stanford Center for Sleep Sciences and Medicine; 🇺🇸 Redwood City, California, United States

SDS Clinical Trials, Inc.; 🇺🇸 Santa Ana, California, United States

Delta Waves LLC - Hunt - PPDS; 🇺🇸 Colorado Springs, Colorado, United States

Florida Pediatric Research Institute; 🇺🇸 Orlando, Florida, United States

Neurotrials Research; 🇺🇸 Atlanta, Georgia, United States

Georgia Neuro Center; 🇺🇸 Gainesville, Georgia, United States

Neurocare Inc; 🇺🇸 Newton, Massachusetts, United States

Henry Ford Medical Center - Columbus; 🇺🇸 Novi, Michigan, United States

Research Carolina Elite; 🇺🇸 Denver, North Carolina, United States

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