A Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy
- Conditions
- arcolepsy without Cataplexy (Type 2)MedDRA version: 20.0Level: PTClassification code 10028713Term: NarcolepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2022-002966-34-SE
- Lead Sponsor
- Takeda Development Center Americas, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. The participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
2. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form [ICF] and/or electronic consent) and any required privacy authorization before the initiation of any study procedures
Age and Body Mass Index
1. The participant is aged 18 to 70 years, inclusive, at the time of signing the ICF.
Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
2. The participant has body mass index within the range 18 to 40 kg/m2 (inclusive)
Type of Participant and Disease Characteristics
1. The participant has an ICSD-3 diagnosis of NT2 by PSG/MSLT, performed within the past 5 years and meeting the minimal acceptable criteria for the proper performance of PSG/MSLT as outlined in the ICSD-3.
Note: If there is a potential participant with NT2 for whom a diagnostic nPSG/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT before Day -2.
2. The participant has an ESS score >12 on Day -1.
3. The participant is judged by the investigator to be sufficiently healthy to participate in the study, on the basis of clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the screening visit and before the first dose of study drug.
Note: Screening laboratory assessments may be repeated; the sponsor or designee should be informed.
Contraception
1. The participant agrees to follow the birth control requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Medical Conditions
1. The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS
a. Restless legs syndrome/periodic limb movement disorder that has a significant impact on daytime sleepiness
b. Clinically significant moderate-to-severe obstructive sleep apnea (with or without treatment) or obstructive sleep apnea of any severity treated with positive airway pressure or oral appliance.
c. Past PSG data demonstrating any of the following: apnea hypopnea index =15, apnea index =10, or periodic leg movement arousal index of =15/hour, unless a more recent PSG and/or clinical evaluation by
the investigator indicates a meaningful change in clinical status. All attempts should be made to confirm eligibility based on Day -2 nPSG data
2. The participant has a current medical condition such as unstable cardiovascular, pulmonary, renal, or gastrointestinal disease, that would preclude enrollment in the view of the investigator
3. The participant has medically significant hepatic or thyroid disease.
4. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. Any history of Roux-en-Y gastric bypass is considered exclusionary, and any other surgical intervention that may influence
the absorption of drugs should be discussed and approved by the sponsor or designee before enrolling the participant
5. 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 cancer; these participants may be included after approval by the sponsor or designee)
6. The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure
7. The participant has a clinically significant history of head injury or head trauma
8. The participant has a 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)
9. 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 (DSM-5)
c. Current diagnosis or history of substance use disorder as defined in the DSM-5.
d. Current active (MDE) or who have had an active MDE in the past 6 months.
10. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
11. The participant has a current history of significant multiple or severe allergies or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food
12. The participant has a known hypersensitivity to any component of the formulation of TAK-861 or related compounds.
13. The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit
14. The participant is unable to refrain from
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of TAK-861 on EDS as measured by sleep latency from the MWT;Secondary Objective: - To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score. <br>- To evaluate the safety and tolerability of TAK-861<br>;Primary end point(s): Change from baseline to Week 8 in mean sleep latency from the MWT;Timepoint(s) of evaluation of this end point: week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline to Week 8 in ESS total score<br>- Occurrence of at least 1 treatment-emergent adverse event (TEAE)<br>;Timepoint(s) of evaluation of this end point: week 8