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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517711-70-01 | EU Trial (CTIS) Number |
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Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.
Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-360 | Experimental | Participants will receive TAK-360 tablets, orally, for 4 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-360 | Drug | TAK-360 tablet. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | 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. | Up to 15 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline at Week 4 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. |
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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 36 | Recruiting | Auburn | Alabama | 36832 | United States | |
| Takeda Site 39 |
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| Label | URL |
|---|---|
| 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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| Other |
TAK-360 matching placebo tablet. |
|
| Baseline, Week 4 |
| Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) | 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. | Baseline, Week 4 |
| Recruiting |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Takeda Site 40 | Recruiting | Chula Vista | California | 91910 | United States |
| Takeda Site 14 | Recruiting | Redwood City | California | 94063-3132 | United States |
| Takeda Site 10 | Recruiting | Santa Ana | California | 92705-8519 | United States |
| Takeda Site 1 | Recruiting | Colorado Springs | Colorado | 80918-3408 | United States |
| Takeda Site 48 | Not yet recruiting | Bradenton | Florida | 34209 | United States |
| Takeda Site 13 | Recruiting | Brandon | Florida | 33511-5719 | United States |
| Takeda Site 46 | Not yet recruiting | Jacksonville | Florida | 32209 | United States |
| Takeda Site 44 | Recruiting | Miami | Florida | 33155 | United States |
| Takeda Site 35 | Recruiting | Miami | Florida | 33176 | United States |
| Takeda Site 3 | Recruiting | Orlando | Florida | 32803-1468 | United States |
| Takeda Site 33 | Recruiting | Orlando | Florida | 32807 | United States |
| Takeda Site 32 | Recruiting | Atlanta | Georgia | 30328 | United States |
| Takeda Site 49 | Not yet recruiting | Bowie | Maryland | 20715 | United States |
| Takeda Site 50 | Not yet recruiting | Lansing | Michigan | 48911 | United States |
| Takeda Site 34 | Recruiting | Lathrup Village | Michigan | 48076 | United States |
| Takeda Site 4 | Recruiting | St Louis | Missouri | 63123-6968 | United States |
| Takeda Site 37 | Recruiting | Middletown | New Jersey | 07748 | United States |
| Takeda Site 8 | Recruiting | Denver | North Carolina | 28037 | United States |
| Takeda Site 6 | Recruiting | Huntersville | North Carolina | 28078-5082 | United States |
| Takeda Site 41 | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Takeda Site 5 | Recruiting | Cincinnati | Ohio | 45245-4500 | United States |
| Takeda Site 45 | Not yet recruiting | Cleveland | Ohio | 44106 | United States |
| Takeda Site 2 | Recruiting | Columbia | South Carolina | 29201-2923 | United States |
| Takeda Site 38 | Recruiting | Austin | Texas | 78731 | United States |
| Takeda Site 43 | Withdrawn | Dallas | Texas | 75235 | United States |
| Takeda Site 42 | Not yet recruiting | El Paso | Texas | 79912 | United States |
| Takeda Site 47 | Not yet recruiting | Mansfield | Texas | 76063 | United States |
| Takeda Site 7 | Recruiting | San Antonio | Texas | 78229-4849 | United States |
| Takeda Site 11 | Recruiting | Norfolk | Virginia | 23510-1021 | United States |
| Takeda Site 28 | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| Takeda Site 29 | Recruiting | Guangzhou | Guangzhou | 510515 | China |
| Takeda Site 51 | Recruiting | Changchun | Jilin | 130021 | China |
| Takeda Site 27 | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| Takeda Site 17 | Withdrawn | Montpellier | Hérault | 34090 | France |
| Takeda Site 15 | Recruiting | Paris | 75013 | France |
| Takeda Site 22 | Recruiting | Rome | Lazio | 133 | Italy |
| Takeda Site 31 | Recruiting | Verona | Veneto | 37134 | Italy |
| Takeda Site 23 | Recruiting | Bologna | 40139 | Italy |
| Takeda Site 24 | Recruiting | Kohoku-ku, Yokohama-Shi | Kanagawa | 222-0033 | Japan |
| Takeda Site 9 | Recruiting | Kumamoto | Kumamoto | 862-0954 | Japan |
| Takeda Site 53 | Not yet recruiting | Isahaya-shi | Nagasaki | 854-0081 | Japan |
| Takeda Site 30 | Recruiting | Urasoe-Shi | Okinawa | 901-2132 | Japan |
| Takeda Site 20 | Recruiting | Shinjuku-ku | Tokyo | 162-0851 | Japan |
| Takeda Site 26 | Recruiting | Sumida-Ku | Tokyo | 130-0004 | Japan |
| Takeda Site 52 | Recruiting | Fukuoka | 812-0025 | Japan |
| Takeda Site 12 | Recruiting | Yodogawa-ku, Osaka-shi | Ôsaka | 532-0003 | Japan |
| Takeda Site 16 | Recruiting | Junggu | Daegu Gwang'yeogsi | South Korea |
| Takeda Site 19 | Recruiting | Suwon | Gyeonggido | 16247 | South Korea |
| Takeda Site 21 | Recruiting | Seoul | Seoul Teugbyeolsi | 3080 | South Korea |
| Takeda Site 18 | Recruiting | Madrid | 28046 | Spain |