A Study of TAK-360 in Adults With Idiopathic Hypersomnia
ConditionIdiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTakeda
About this trial
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.
The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that.
Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m²) [inclusive].
The participant has a documented, current diagnosis of IH.
Disqualifiers
The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].
The participant has medically significant thyroid disease.
The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
Trial design
Design model
Parallel
Treatments tested in this trial
TAK-360
DrugTAK-360 tablet.
Placebo
Other interventionTAK-360 matching placebo tablet.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: TAK-360Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Time frame
Up to Week 8Secondary outcomes
1
Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
Time frame
Baseline, Week 42
Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score
IHSS is a 14-item self-assessment questionnaire, to measure the severity, frequency and functional impact of the three key IH symptoms (during a recall period of "past 7 days"). The IHSS includes 14 items in total; two items (1 and 2) on nighttime sleep duration and quality, three items (3, 4 and 5) on sleep inertia and sleep drunkenness after nighttime sleep and one (8) after daytime nap, and three items (6, 7 and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10 to 14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and eight items on a 4-point Likert scale; the Likert scale is a point scale which is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0 to 50), and higher scores indicate more severe symptoms.
Time frame
Baseline, Week 4 Source ClinicalTrials.gov