Trial Outcomes & Findings for A Study of TAK-861 in Participants With Narcolepsy Type 2 (NCT NCT05687916)

Last Updated: 2025-01-09

Results Overview

The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2025-01-09

Participant Flow

Participants took part in the study at 28 investigative sites globally from 09 January 2023 to 25 December 2023.

Participants with a diagnosis of narcolepsy type 2 (NT2) were enrolled in the study to receive either TAK-861 or placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.	TAK-861 2 mg BID Participants received TAK-861 2 milligrams (mg), orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Overall Study STARTED	24	23	24
Overall Study COMPLETED	21	19	22
Overall Study NOT COMPLETED	3	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.	TAK-861 2 mg BID Participants received TAK-861 2 milligrams (mg), orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Overall Study Adverse Event	1	2	0
Overall Study Withdrawal by Subject	1	0	1
Overall Study Protocol Violation	0	2	1
Overall Study Reason not Specified	1	0	0

Baseline Characteristics

A Study of TAK-861 in Participants With Narcolepsy Type 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=24 Participants Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.	TAK-861 2 mg BID n=23 Participants Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg n=24 Participants Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.	Total n=71 Participants Total of all reporting groups
Age, Continuous	37.0 years STANDARD_DEVIATION 12.69 • n=5 Participants	34.9 years STANDARD_DEVIATION 9.77 • n=7 Participants	36.8 years STANDARD_DEVIATION 12.61 • n=5 Participants	36.2 years STANDARD_DEVIATION 11.66 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	19 Participants n=7 Participants	14 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Average Sleep Latency From the Maintenance of Wakefulness Test (MWT)	10.8 minutes STANDARD_DEVIATION 8.72 • n=5 Participants	9.9 minutes STANDARD_DEVIATION 10.29 • n=7 Participants	8.4 minutes STANDARD_DEVIATION 8.26 • n=5 Participants	9.7 minutes STANDARD_DEVIATION 9.04 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: The Full Analysis Set included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.	TAK-861 2 mg BID n=19 Participants Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg n=22 Participants Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8	2.14 minutes Standard Error 2.246	1.90 minutes Standard Error 2.384	4.54 minutes Standard Error 2.300

SECONDARY outcome

Timeframe: Baseline, Week 8

The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. 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. The MMRM was used for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.	TAK-861 2 mg BID n=19 Participants Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg n=22 Participants Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8	-3.39 score on a scale Standard Error 1.140	-3.71 score on a scale Standard Error 1.206	-6.45 score on a scale Standard Error 1.121

SECONDARY outcome

Timeframe: From first dose of the study drug up to end of the study (up to 3 months)

Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, 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 was defined as an AE whose date of onset occurred on or after the first dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.	TAK-861 2 mg BID n=23 Participants Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg n=24 Participants Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)	8 Participants	10 Participants	18 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

TAK-861 2 mg BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

TAK-861 2 mg and 5 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=24 participants at risk Participants received placebo tablets (\]matching TAK-861, orally, twice daily (BID), from Days 1 to 56.	TAK-861 2 mg BID n=23 participants at risk Participants received TAK-861 2 milligrams (mg), orally, BID, from Days 1 to 56.	TAK-861 2 mg and 5 mg n=24 participants at risk Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Nervous system disorders Headache	0.00% 0/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/23 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 2/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	8.3% 2/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.7% 2/23 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.8% 5/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Micturition urgency	0.00% 0/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.3% 1/23 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 2/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis streptococcal	0.00% 0/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.7% 2/23 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	13.0% 3/23 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 8/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/23 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 2/24 • From first dose of the study drug up to end of the study (up to 3 months) The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place