BridgeMD
A Trial to Evaluate the Long-term Safety and Tolerability of TAK-861
EU CTIS ID: 2023-508462-15-00
What this study is testing
To evaluate the long-term safety and tolerability of TAK-861.
- Phase II and Phase III (Integrated)
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
- Participant with a diagnosis of NT1 who has completed a controlled Trial with TAK-861, who meet all inclusion criteria and does not meet any exclusion criteria, and for whom the investigator has no clinical objection to their enrollment.
You likely can't join if
- Participant has a treatment-related adverse event (TEAE) that remains severe at the time of rollover related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
- Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage.
- Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- 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 skin cancer; these participants may be included after approval by the sponsor or designee).
- The participant has a positive urine screen result for drugs of abuse and/or positive alcohol test result at screening or at Day -2 if a dosing gap > 7 days is present. An exception at screening is made for stimulants or other drugs the participant has been prescribed.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale Since Last Visit (C-SSRS) on any visit in the prior study or has positive answers on item 4 or 5 on the C-SSRS Screening/Baseline (based on the past year) during the screening assessment for participants with a dosing gap.
See the full eligibility criteria
Who can join
- Participant with a diagnosis of NT1 who has completed a controlled Trial with TAK-861, who meet all inclusion criteria and does not meet any exclusion criteria, and for whom the investigator has no clinical objection to their enrollment.
What rules you out
- Participant has a treatment-related adverse event (TEAE) that remains severe at the time of rollover related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
- Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage.
- Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- 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 skin cancer; these participants may be included after approval by the sponsor or designee).
- The participant has a positive urine screen result for drugs of abuse and/or positive alcohol test result at screening or at Day -2 if a dosing gap > 7 days is present. An exception at screening is made for stimulants or other drugs the participant has been prescribed.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale Since Last Visit (C-SSRS) on any visit in the prior study or has positive answers on item 4 or 5 on the C-SSRS Screening/Baseline (based on the past year) during the screening assessment for participants with a dosing gap.
- Participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap.
- Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
- Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).
- Participant has epilepsy or history of seizure.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Canada
- Switzerland
- United States
- Australia
- Japan
- Korea, Republic of
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 China; Canada; Switzerland; United States; Australia; Japan and 1 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 EU CTIS; the study team decides eligibility.