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A Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy
EU CTIS ID: 2024-511998-30-00
What this study is testing
To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female participants aged 18 to 70 years, inclusive, at the time of signing the ICF.
- The participant has a body mass index within the range 18 to 40 kg/m2 (inclusive).
- The participant has an ICSD-3 or ICSD-3-TR diagnosis of NT1.
- The participant has ≥4 partial or complete episodes of cataplexy/week (WCR).
- The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant’s CSF OX/hypocretin-1 concentration is <110 pg/mL
- The participant is judged by the investigator to be sufficiently healthy to participate in the study, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before the first dose of study drug.
You likely can't join if
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- The participant has had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
- The participant has a history of myocardial infarction, has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease)
- 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 (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 sponsor or designee).
- The participant has a clinically significant history of head injury or head trauma.
See the full eligibility criteria
Who can join
- Male or female participants aged 18 to 70 years, inclusive, at the time of signing the ICF.
- The participant has a body mass index within the range 18 to 40 kg/m2 (inclusive).
- The participant has an ICSD-3 or ICSD-3-TR diagnosis of NT1.
- The participant has ≥4 partial or complete episodes of cataplexy/week (WCR).
- The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant’s CSF OX/hypocretin-1 concentration is <110 pg/mL
- The participant is judged by the investigator to be sufficiently healthy to participate in the study, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before the first dose of study drug.
What rules you out
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- The participant has had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
- The participant has a history of myocardial infarction, has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease)
- 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 (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 sponsor or designee).
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion.
- The participant has any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.
- The participant has a current history of significant multiple or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- The participant has a known hypersensitivity to any component of the formulation of TAK-861 or related compounds.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Republic of
- China
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Republic of; China. 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 EU CTIS; the study team decides eligibility.