Evaluating TAK-861 for treating narcolepsy type 1

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 aims to assess the safety and tolerability of TAK-861 in participants diagnosed with narcolepsy type 1 who have previously participated in controlled studies with the drug. The trial will monitor improvements in narcolepsy symptoms, particularly excessive daytime sleepiness and cataplexy episodes. Up to 500 patients will be enrolled, and they will receive either of two doses of TAK-861 based on their prior treatment. The study is a long-term extension that will last approximately five years and is conducted across multiple centers worldwide.

Why it matters

Who can join: the full rules

Inclusion criteria:

1\. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.

Exclusion criteria:

1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (\>) 1.5 times the upper limit of normal (ULN).
4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
7. Participant has epilepsy or history of seizure.
8. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
9. Participant has a history of cerebral ischemia, transient ischemic attack (less than (\<) 5 years ago), or cerebral hemorrhage.
10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
11. Participant has a history of cancer in the past 5 years.

Where it's running

• Sleep Disorders Center of Alabama
  Birmingham, Alabama, United States Recruiting
• Stanford Center for Sleep Sciences and Medicine
  Redwood City, California, United States Recruiting
• SDS Clinical Trials, Inc.
  Santa Ana, California, United States Recruiting
• Delta Waves LLC - Hunt - PPDS
  Colorado Springs, Colorado, United States Recruiting
• Florida Pediatric Research Institute
  Orlando, Florida, United States Recruiting
• Neurotrials Research
  Atlanta, Georgia, 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.

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• TAK-360 in adults with narcolepsy Type 1 with cataplexy

  This study tests TAK-360 versus placebo in adults with narcolepsy Type 1 to see if it is safe and tolerable.

  Recruiting at 9 sites Phase 2 Takeda · Redwood City, California and 17 other locations · NCT07633301

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

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  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.

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• 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.

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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.