A Study of TAK-861 in Participants With Narcolepsy Type 2

• ClinicalTrials.gov Identifier: NCT05687916
• Recruitment Status: Completed
• First Posted: January 18, 2023
• Last Update Posted: May 17, 2024
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Tracking Information

• First Submitted Date: January 9, 2023
• First Posted Date: January 18, 2023
• Last Update Posted Date: May 17, 2024
• Actual Study Start Date: January 9, 2023
• Actual Primary Completion Date: December 25, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2023)

Change from Baseline to Week 8 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline, Week 8 ]

The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 9, 2023)

• Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score [ Time Frame: Baseline, Week 8 ]
  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.
• Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) [ Time Frame: From baseline up to approximately 12 weeks ]
  An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of TAK-861 in Participants With Narcolepsy Type 2
• Official Title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)

Brief Summary

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).

The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Detailed Description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy [Narcolepsy Type 2 (NT2)]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861.

The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• TAK-861 Dose 1
• TAK-861 Dose 2
• Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Narcolepsy Type 2

Intervention

• Drug: TAK-861
  TAK-861 tablets.
• Drug: Placebo
  TAK-861 placebo matching tablets.

Study Arms

• Experimental: TAK-861 Dose 1
  TAK-861 dose 1, orally for 8 weeks.
  Intervention: Drug: TAK-861
• Experimental: TAK-861 Dose 2
  TAK-861 dose 2, orally for 8 weeks.
  Intervention: Drug: TAK-861
• Placebo Comparator: Placebo
  TAK-861 matching placebo tablets, orally for 8 weeks.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 16, 2024): 71
• Original Estimated Enrollment (submitted: January 9, 2023): 60
• Actual Study Completion Date: December 25, 2023
• Actual Primary Completion Date: December 25, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).

Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.

- The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.

Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.

Exclusion Criteria:

• The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
• The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).

• The participant has one or more of the following psychiatric disorders:

  1. Any current unstable psychiatric disorder.
  2. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
  3. Current diagnosis or history of substance use disorder as defined in the DSM-5. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
  4. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
• The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
• The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United States

Administrative Information

• NCT Number: NCT05687916
• Other Study ID Numbers: TAK-861-2002; 2022-002966-34 ( EudraCT Number ); U1111-1277-4261 ( Other Identifier: WHO Universal Trial Number ); jRCT2031230050 ( Registry Identifier: jRCT )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• URL: https://vivli.org/ourmember/takeda/

• Current Responsible Party: Takeda
• Original Responsible Party: Same as current
• Current Study Sponsor: Takeda
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Takeda

• PRS Account: Takeda
• Verification Date: May 2024