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New treatment option for Idiopathic Hypersomnia
Official title A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
ClinicalTrials.gov ID: NCT07646678
What this study is testing
What is TAK-360?
TAK-360 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic hypersomnia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 71
You may be able to join if
- Participant is willing and able to understand and fully comply with trial procedures and requirements.
- Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
- Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required...
You likely can't join if
- Participant has a positive pregnancy test or is lactating/breastfeeding.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- Participant has developed a new history of seizures.
- Participant has experienced clinically significant head injury, per investigator opinion.
See the full eligibility criteria
- Participant is willing and able to understand and fully comply with trial procedures and requirements.
- Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
- Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures. Key
- Participant has a positive pregnancy test or is lactating/breastfeeding.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- Participant has developed a new history of seizures.
- Participant has experienced clinically significant head injury, per investigator opinion.
- Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [\<] 5 years ago), or cerebral haemorrhage.
- Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.
- Participant has developed a history of cancer in the past 5 years.
The study team makes the final eligibility decision.
Where it's taking place
- Shinjuku-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 71 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shinjuku-ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.