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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522587-33-00 | EU Trial (CTIS) Number | ||
| jRCT2031260186 | Other Identifier | jRCT |
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Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.
The participants will have to visit the clinic multiple times during this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: TAK-360 | Experimental | Participants will receive TAK-360 tablets, orally. |
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| Part A: Placebo | Placebo Comparator | Participants will receive TAK-360 matching placebo tablets, orally. |
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| Part B: TAK-360 | Experimental | Participants will receive TAK-360 tablets, orally. |
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| Part B: Placebo | Placebo Comparator | Participants will receive TAK-360 matching placebo tablets, orally. |
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| Part C | Experimental | Participants will receive TAK-360 tablets, orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-360 | Drug | TAK-360 tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. 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. | Up to approximately 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6 | 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. | Baseline, Week 6 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Site 12 | Not yet recruiting | Redwood City | California | 94063 | United States | |
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| Label | URL |
|---|---|
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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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.
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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.
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Placebo |
| Drug |
TAK-360 matching placebo tablet |
|
| Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6 | 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 reference range. | Baseline, Week 6 |
| Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6 | Week 6 |
| Takeda Site 14 |
| Recruiting |
| Miami |
| Florida |
| 33176 |
| United States |
| Takeda Site 13 | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Takeda Site 2 | Not yet recruiting | Macquarie Park | New South Wales | 2113 | Australia |
| Takeda Site 4 | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| Takeda Site 3 | Recruiting | Guangzhou | Guangdong | 510515 | China |
| Takeda Site 5 | Recruiting | Zhengzhou | Henan | 450003 | China |
| Takeda Site 6 | Not yet recruiting | Herault | Montpelier | 34000 | France |
| Takeda Site 7 | Not yet recruiting | Paris | 75013 | France |
| Takeda Site 8 | Not yet recruiting | Bologna | Emilia-Romagna | 40139 | Italy |
| Takeda Site 9 | Not yet recruiting | Verona | Veneto | 37134 | Italy |
| Takeda Site 17 | Recruiting | Fukuoka | Fukuoka | 812-0025 | Japan |
| Takeda Site 1 | Recruiting | Kumamoto | Kumamoto | 862-0954 | Japan |
| Takeda Site 18 | Recruiting | Isahaya-shi | Nagasaki | 854-0081 | Japan |
| Takeda Site 15 | Not yet recruiting | Yodogawa-ku, Osaka-shi | Osaka | 532-0003 | Japan |
| Takeda Site 16 | Recruiting | Shinjuku-ku | Tokyo | 162-0851 | Japan |
| Takeda Site 11 | Not yet recruiting | Barcelona | 8036 | Spain |
| Takeda Site 10 | Not yet recruiting | Madrid | 28043 | Spain |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |