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New treatment option for Narcolepsy Type 1 (NT1)
Official title A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
ClinicalTrials.gov ID: NCT07363720
What this study is testing
What is TAK-861?
TAK-861 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for narcolepsy type 1 (nt1).
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
- The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.
- Phase 3: a large, late-stage study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 70
You may be able to join if
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders...
- The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\ 06:02) or...
You likely can't join if
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary...
- The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- The participant has a history of cancer in the past 5 years.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
See the full eligibility criteria
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
- The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\ 06:02) or results from radioimmunoassay indicate the participant's CSF...
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure, or c) has any...
- The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- The participant has a history of cancer in the past 5 years.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Brandon, Florida, United States
- Miami, Florida, United States
- Southfield, Michigan, United States
- Middletown, New Jersey, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbia, South Carolina, United States
- Austin, Texas, United States
- Montpellier, France
- Paris, France
- Toulouse, France
- Schwerin, Mecklenburg-Vorpommern, Germany
- Berlin, Germany
- Bologna, Emilia-Romagna, Italy
- Rome, Lazio, Italy
- Heemstede, Netherlands
- Vitoria-Gasteiz, Alava, Spain
+ 5 more site(s).
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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Brandon, Florida, United States; Miami, Florida, United States; Southfield, Michigan, United States; Middletown, New Jersey, United States; Durham, North Carolina, United States and 19 more location(s). 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.