TAK-360 in adults with narcolepsy Type 1 with cataplexy

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 Phase 2 trial evaluates safety and tolerability of TAK-360 in adults with narcolepsy Type 1 (with cataplexy). Participants stop their current NT1 medicines before starting the study medication, then are randomly assigned to TAK-360 or placebo for a treatment period, followed by a 2-week follow-up. The trial uses a double-blind, placebo-controlled design to compare safety signals and tolerability between groups. After the treatment period, participants may restart their usual NT1 therapy under supervision.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive).
2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.

Key Exclusion Criteria:

1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
3. The participant has a clinically significant history of head injury or head trauma.
4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
5. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
6. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor).
7. The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
8. The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004.
9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.

Where it's running

• Takeda Site 14
  Miami, Florida, United States Recruiting
• Takeda Site 13
  Cincinnati, Ohio, United States Recruiting
• Takeda Site 4
  Beijing, Beijing Municipality, China Recruiting
• Takeda Site 3
  Guangzhou, Guangdong, China Recruiting
• Takeda Site 5
  Zhengzhou, Henan, China Recruiting
• Takeda Site 17
  Fukuoka, Fukuoka, Japan Recruiting

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.

• Temporal interference stimulation for narcolepsy type 1

  A noninvasive brain stimulation test to see if theta-burst temporal interference can help people with narcolepsy type 1.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07727239

• 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 in adults with narcolepsy type 1: see if it helps daytime sleepiness and cataplexy

  This study tests whether ALKS 2680 helps reduce daytime sleepiness and cataplexy in adults with narcolepsy type 1 compared with a placebo.

  Recruiting at 20 sites Phase 3 Alkermes, Inc. · Brandon, Florida and 19 other locations · NCT07540897

• ALKS 2680 for reducing daytime sleepiness and cataplexy in adults with narcolepsy type 1

  This study will test whether ALKS 2680 tablets can reduce daytime sleepiness, cataplexy, and other symptoms in adults with narcolepsy type 1.

  Recruiting at 44 sites Phase 3 Alkermes, Inc. · Cullman, Alabama and 43 other locations · NCT07455383

• Pain testing for people with idiopathic REM sleep behavior disorder

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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.