A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
ConditionNarcolepsy Type 1
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age16-70
SponsorTakeda
About this trial
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
Trial design
Design model
Single group
Treatments tested in this trial
TAK-861
DrugTAK-861 tablets
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: TAK-861Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving trial intervention.
Time frame
From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)Secondary outcomes
1
Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Time frame
Baseline (parent trial), Week 26 (current LTE trial)2
Change from Baseline in the Parent Trial 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 (parent trial); Week 2 through Year 5 (current LTE trial)3
Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary
Participants will record episodes of cataplexy in the diary throughout the trial.
Time frame
Baseline (parent trial); Year 1 through Year 5 (current LTE trial) Source ClinicalTrials.gov