A Study of TAK-861 in Participants With Narcolepsy Type 2
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| ClinicalTrials.gov Identifier: NCT05687916 |
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Recruitment Status :
Active, not recruiting
First Posted : January 18, 2023
Last Update Posted : November 1, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Narcolepsy Type 2 | Drug: TAK-861 Drug: Placebo | Phase 2 |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | January 9, 2023 |
| Estimated Primary Completion Date : | May 17, 2024 |
| Estimated Study Completion Date : | October 5, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: TAK-861 Dose 1
TAK-861 dose 1, orally for 8 weeks.
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Drug: TAK-861
TAK-861 tablets. |
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Experimental: TAK-861 Dose 2
TAK-861 dose 2, orally for 8 weeks.
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Drug: TAK-861
TAK-861 tablets. |
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Placebo Comparator: Placebo
TAK-861 matching placebo tablets, orally for 8 weeks.
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Drug: Placebo
TAK-861 placebo matching tablets. |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
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The participant has one or more of the following psychiatric disorders:
- Any current unstable psychiatric disorder.
- 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).
- 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.)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05687916
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| Study Director: | Study Director | Takeda |
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | 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 ) |
| First Posted: | January 18, 2023 Key Record Dates |
| Last Update Posted: | November 1, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (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 Statistical Analysis Plan (SAP) Informed Consent Form (ICF) 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/ |
| 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 |
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Drug Therapy |
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Narcolepsy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |