Narcolepsy type 2 sleeping disorder
Conditions
Interventions
The following treatments will be administered orally:
• TAK-861 Dose Regimen 1: 2 mg twice daily approximately 3 hours apart
• TAK-861 Dose Regimen 2: 7 mg once daily (QD) or 2 mg followed by 5 mg
ap
the decision will be made before randomization of the
first participant.
Study treatment will be administered at approximately 8 am and 11 am.
(Participants assigned to a QD dose regimen will rece
Sponsors
Takeda Development Center Americas, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF). 2. The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years. Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.
Exclusion criteria
Exclusion criteria: 1. The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS. 2. The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood). 3. The participant has one or more of the following psychiatric disorders: a. Any current unstable psychiatric disorder. b. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). c. Current diagnosis or history of substance use disorder as defined in the DSM-5. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.) d. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months. 4. The participant has a history of cerebral ischemia, transient ischemic attack (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 8 in mean sleep latency from the MWT. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline to Week 8 in ESS total score. - Occurrence of at least 1 TEAE. For additional / exploratory endpoints please refer to the study protocol. | — |
Countries
Netherlands
Outcome results
None listed