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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy without Cataplexy (Narcolepsy Type 2)

    Summary
    EudraCT number
    2022-002966-34
    Trial protocol
    NO   SE   FR   IT   ES   FI  
    Global end of trial date
    25 Dec 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Dec 2024
    First version publication date
    29 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-861-2002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05687916
    WHO universal trial number (UTN)
    U1111-1282-8382
    Other trial identifiers
    jRCT: jRCT2031230050
    Sponsors
    Sponsor organisation name
    Takeda Development Center Americas, Inc.
    Sponsor organisation address
    95 Hayden Avenue, Lexington, Massachusetts, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).
    Protection of trial subjects
    All study participants were required to read and sign an informed consent form (ICF).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Jan 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 41
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Japan: 8
    Worldwide total number of subjects
    71
    EEA total number of subjects
    22
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    70
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Placebo
    Arm description
    Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered TAK-861 matching placebo tablet twice a day 3 hours apart or once a day as required.

    Arm title
    TAK-861 2 mg BID
    Arm description
    Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
    Arm type
    Experimental

    Investigational medicinal product name
    TAK-861
    Investigational medicinal product code
    TAK-861
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered TAK-861 2 milligrams (mg) tablets twice a day 3 hours apart.

    Arm title
    TAK-861 2 mg and 5 mg
    Arm description
    Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
    Arm type
    Experimental

    Investigational medicinal product name
    TAK-861
    Investigational medicinal product code
    TAK-861
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered TAK-861 2 mg followed by 5 mg 3 hours apart or TAK-861 7mg once daily.

    Number of subjects in period 1
    Placebo TAK-861 2 mg BID TAK-861 2 mg and 5 mg
    Started
    24
    23
    24
    Completed
    21
    19
    22
    Not completed
    3
    4
    2
         Consent withdrawn by subject
    1
    -
    1
         Adverse event, non-fatal
    1
    2
    -
         Reason not Specified
    1
    -
    -
         Protocol deviation
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.

    Reporting group title
    TAK-861 2 mg BID
    Reporting group description
    Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

    Reporting group title
    TAK-861 2 mg and 5 mg
    Reporting group description
    Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

    Reporting group values
    Placebo TAK-861 2 mg BID TAK-861 2 mg and 5 mg Total
    Number of subjects
    24 23 24
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.0 ( 12.69 ) 34.9 ( 9.77 ) 36.8 ( 12.61 ) -
    Gender categorical
    Units: Subjects
        Female
    18 14 17 49
        Male
    6 9 7 22
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    6 5 2 13
        Not Hispanic or Latino
    18 18 20 56
        Unknown or Not Reported
    0 0 2 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    3 3 3 9
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    7 1 5 13
        White
    13 19 14 46
        More than one race
    0 0 0 0
        Unknown or Not Reported
    1 0 2 3
    Average Sleep Latency From the Maintenance of Wakefulness Test (MWT)
    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 electroencephalography (EEG). If no sleep was observed according to these rules, then the latency was defined as 40 minutes.
    Units: minutes
        arithmetic mean (standard deviation)
    10.8 ( 8.72 ) 9.9 ( 10.29 ) 8.4 ( 8.26 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.

    Reporting group title
    TAK-861 2 mg BID
    Reporting group description
    Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

    Reporting group title
    TAK-861 2 mg and 5 mg
    Reporting group description
    Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

    Primary: Change from Baseline in the Average Sleep Latency as Determined From the MWT at Week 8

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    End point title
    Change from Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
    End point description
    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. 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. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Baseline, Week 8
    End point values
    Placebo TAK-861 2 mg BID TAK-861 2 mg and 5 mg
    Number of subjects analysed
    21
    19
    22
    Units: minutes
        least squares mean (standard error)
    2.14 ( 2.246 )
    1.90 ( 2.384 )
    4.54 ( 2.300 )
    Statistical analysis title
    Average Sleep Latency
    Comparison groups
    Placebo v TAK-861 2 mg BID
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.989 [1]
    Method
    MMRM
    Parameter type
    LS Mean Difference Estimate
    Point estimate
    -0.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.67
         upper limit
    6.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.277
    Notes
    [1] - The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. The p-value reported is adjusted for multiplicity.
    Statistical analysis title
    Average Sleep Latency
    Comparison groups
    Placebo v TAK-861 2 mg and 5 mg
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.916 [2]
    Method
    MMRM
    Parameter type
    LS Mean Difference Estimate
    Point estimate
    2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.93
         upper limit
    8.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.227
    Notes
    [2] - The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. The p-value reported is adjusted for multiplicity.

    Secondary: Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE)

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    End point title
    Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE)
    End point description
    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. The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of the study drug up to end of the study (up to 3 months)
    End point values
    Placebo TAK-861 2 mg BID TAK-861 2 mg and 5 mg
    Number of subjects analysed
    24
    23
    24
    Units: participants
    8
    10
    18
    No statistical analyses for this end point

    Secondary: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8

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    End point title
    Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8
    End point description
    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. 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. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Placebo TAK-861 2 mg BID TAK-861 2 mg and 5 mg
    Number of subjects analysed
    20
    19
    22
    Units: score on a scale
        least squares mean (standard error)
    -3.39 ( 1.140 )
    -3.71 ( 1.206 )
    -6.45 ( 1.121 )
    Statistical analysis title
    Epworth Sleepiness Scale (ESS) Total Score
    Comparison groups
    Placebo v TAK-861 2 mg and 5 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.216 [3]
    Method
    MMRM
    Parameter type
    LS Mean Difference Estimate
    Point estimate
    -3.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.18
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.59
    Notes
    [3] - The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. The p-value reported is adjusted for multiplicity.
    Statistical analysis title
    Epworth Sleepiness Scale (ESS) Total Score
    Comparison groups
    Placebo v TAK-861 2 mg BID
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.989 [4]
    Method
    MMRM
    Parameter type
    LS Mean Difference Estimate
    Point estimate
    -0.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.57
         upper limit
    2.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.656
    Notes
    [4] - The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. The p-value reported is adjusted for multiplicity.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of the study drug up to end of the study (up to 3 months)
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo tablets (]matching TAK-861, orally, twice daily (BID), from Days 1 to 56.

    Reporting group title
    TAK-861 2 mg and 5 mg
    Reporting group description
    Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

    Reporting group title
    TAK-861 2 mg BID
    Reporting group description
    Participants received TAK-861 2 milligrams (mg), orally, BID, from Days 1 to 56.

    Serious adverse events
    Placebo TAK-861 2 mg and 5 mg TAK-861 2 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo TAK-861 2 mg and 5 mg TAK-861 2 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    14 / 24 (58.33%)
    7 / 23 (30.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Micturition urgency
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    1
    Pollakiuria
         subjects affected / exposed
    0 / 24 (0.00%)
    8 / 24 (33.33%)
    3 / 23 (13.04%)
         occurrences all number
    0
    9
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 24 (8.33%)
    5 / 24 (20.83%)
    2 / 23 (8.70%)
         occurrences all number
    2
    5
    2
    Infections and infestations
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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