A long-term extension study to assess the safety and tolerability of TAK 861 in participants with selected central hypersomnias
Descrizione riassuntiva dello studio
We want to investigate the long-term safety and tolerability of several previously tested oral doses of the drug TAK-861 in participants with narcolepsy type 1 (NT1). The investigational drug is not yet approved in Switzerland. Approximately 500 (male and female) participants with narcolepsy type 1 will be assigned a specific dosage and will be asked to take the investigational drug for several years. Participants are only eligible for this study if they have participated in a previous controlled study of TAK-861. In this study, all participants will receive TAK-861, the investigational drug, but will not know which dose they are receiving. The investigational drug is in tablet form and is taken with a large glass of water. The treatment duration is a maximum of 5 years. In the first year of the study, there will be several visit appointments at the study center. Additionally, further visit appointments will be required. These may take place at the study center, at your home with the help of trained medical professionals, or in a blood testing laboratory. After the first year (Year 1), you will have regular visit appointments at the study center until the completion of the study, but with less frequency than in Year 1. You will need to spend one night at the study center or hospital and will be discharged the next day. At certain visit appointments, you may be asked to provide blood and urine samples, undergo an electrocardiogram (ECG), complete questionnaires about your quality of life, and undergo assessments to evaluate your cognitive performance and ability to stay awake. At certain intervals, participants will be asked to keep a diary at home to record their cataplexy and other symptoms. This can conveniently be done via a mobile or tablet application.
(BASEC)
Intervento studiato
drug TAK-861
(BASEC)
Malattie studiate
selected central hypersomnias
(BASEC)
1. The participant is willing and able to understand and fully comply with the study procedures and requirements (including the use of digital tools and applications) 2. Participants with a narcolepsy diagnosis who have participated in a controlled study with TAK-861 3. The participant agrees to adhere to the listed contraception requirements (BASEC)
Criteri di esclusione
1. The participant has a moderate or severe persistent treatment-related adverse event associated with the study drug from the parent study or has discontinued the parent study due to adverse events. 2. The participant has taken prohibited medications during the parent study and cannot refrain from doing so or expects that they will need to continue taking these medications 3. The participant has a blood pressure over 140/90 at screening, if a dosage gap exists, or a blood pressure over 160/100 if transitioning directly from the parent study. (BASEC)
Luogo dello studio
Berna, Lugano, Altro
(BASEC)
Aargau
(BASEC)
Sponsor
Takeda Development Center Americas, Inc. USA PPD Switzerland GmbH c/o Thermo Fisher Scientific (Schweiz) AG Reinach
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Ramin Khatami
+41 62 857 2020
Ramin.Khatami@clutterbarmelweid.chKlinik Barmelweid
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
04.04.2023
(BASEC)
ID di studio ICTRP
NCT05816382 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants with Selected Central Hypersomnia Conditions (BASEC)
Titolo accademico
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions (ICTRP)
Titolo pubblico
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions (ICTRP)
Malattie studiate
Narcolepsy Type 1 (ICTRP)
Intervento studiato
Drug: TAK-861 (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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. (ICTRP)
non disponibile
Endpoint primari e secondari
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) (ICTRP)
Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT);Change from Baseline in the Parent Trial in Epworth Sleepiness Scale (ESS) Total Score;Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Study Director;Takeda Contact, medinfoUS@takeda.com, +1-877-825-3327, Takeda, (ICTRP)
ID secondari
U1111-1283-1888, jRCT2031230135, 2023-508462-15-00, TAK-861-2003 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05816382 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile