Evaluating TAK-360 for adults with Narcolepsy Type 2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and tolerability of TAK-360, a medication that mimics orexin, in adults diagnosed with Narcolepsy Type 2 (NT2). Participants will be randomly assigned to receive either TAK-360 or a placebo to assess its effectiveness in helping them stay awake during the day. The study aims to determine the appropriate dosage of TAK-360 needed for optimal results. By focusing on NT2, which significantly impacts daily functioning, the research seeks to improve the quality of life for affected individuals.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
2. The participant has a documented, current diagnosis of NT2.

Key Exclusion Criteria:

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
2. The participant has medically significant thyroid disease.
3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Where it's running

• Takeda Site 40
  Chula Vista, California, United States Recruiting
• Takeda Site 14
  Redwood City, California, United States Recruiting
• Takeda Site 10
  Santa Ana, California, United States Recruiting
• Takeda Site 1
  Colorado Springs, Colorado, United States Recruiting
• Takeda Site 48
  Bradenton, Florida, United States Recruiting
• Takeda Site 13
  Brandon, Florida, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term test of TAK-360 in people with narcolepsy or idiopathic hypersomnia

  This study tests TAK-360 over an extended period to see if it is tolerable for people with narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia who completed an earlier TAK-360 trial.

  Recruiting at 33 sites Phase 2/3 Takeda · Chula Vista, California and 32 other locations · NCT07646678

• Test of Cleminorexton vs placebo for central hypersomnolence in NT1/NT2

  This study tests cleminorexton to see if it helps daytime sleepiness in adults with Narcolepsy Type 1 or Type 2 compared with a placebo.

  Recruiting at 26 sites Phase 2/3 Centessa Pharmaceuticals plc · Birmingham, Alabama and 25 other locations · NCT07598708

• ALKS 2680 for adults with Narcolepsy Type 2

  This will test whether ALKS 2680 tablets reduce daytime sleepiness and other symptoms in adults with Narcolepsy Type 2 compared with placebo.

  Recruiting at 43 sites Phase 3 Alkermes, Inc. · Cullman, Alabama and 43 other locations · NCT07502443

• Long-term ORX750 treatment for people with narcolepsy or idiopathic hypersomnia

  This open-label extension will try continued ORX750 treatment in people with narcolepsy or idiopathic hypersomnia who completed the earlier ORX750 parent study.

  Recruiting at 24 sites Phase 2 Centessa Pharmaceuticals (UK) Limited · Auburn, Alabama and 23 other locations · NCT07096674

• Long-term treatment with ALKS 2680 for narcolepsy and idiopathic hypersomnia

  This study is testing how well a new medication called ALKS 2680 works for people with narcolepsy or idiopathic hypersomnia over a long period of time.

  Recruiting at 50 sites Phase 2/3 Alkermes, Inc. · Cullman, Alabama and 49 other locations · NCT06767683

• Testing ORX750 for Narcolepsy and Idiopathic Hypersomnia

  This study is testing a new medication called ORX750 to see if it can help people with narcolepsy or idiopathic hypersomnia feel more awake and improve their daily lives.

  Recruiting at 37 sites Phase 2 Centessa Pharmaceuticals plc · Auburn, Alabama and 36 other locations · NCT06752668

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.