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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)

    Summary
    EudraCT number
    		 2021-003989-12
    Trial protocol
    		 CZ   SK   BG   PL  
    Global end of trial date
    21 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2025
    First version publication date
    26 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NBI-1065845-MDD2024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05203341
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Neurocrine Biosciences, Inc.
    Sponsor organisation address
    6027 Edgewood Bend Court, San Diego, United States, 92130
    Public contact
    Neurocrine Medical Information, Neurocrine Biosciences, Inc., +1 8776413461, medinfo@neurocrine.com
    Scientific contact
    Neurocrine Medical Information, Neurocrine Biosciences, Inc., +1 8776413461, medinfo@neurocrine.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
    05 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice (GCP), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP guidelines, and the laws and regulations of the countries in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 83
    Country: Number of subjects enrolled
    Poland: 26
    Country: Number of subjects enrolled
    Slovakia: 14
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Czechia: 28
    Worldwide total number of subjects
    183
    EEA total number of subjects
    100
    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)
    181
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized 1:1:2 to receive NBI-1065845 as two different doses or placebo orally.

    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, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets identical in appearance to the active product were administered in the same manner on an identical schedule as NBI-1065845

    Arm title
    		 NBI-1065845 1 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    NBI-1065845
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily

    Arm title
    		 NBI-1065845 3 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    NBI-1065845
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily

    Number of subjects in period 1
    		Placebo NBI-1065845 1 mg NBI-1065845 3 mg
    Started
    91
    45
    47
    Received at Least 1 Dose of Study Drug
    91
    45
    47
    Completed
    79
    42
    43
    Not completed
    12
    3
    4
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    3
    2
    1
         Adverse event, non-fatal
    2
    -
    1
         Not specified
    3
    -
    -
         Lost to follow-up
    2
    1
    2
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 183 183
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.4 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 117 117
        Male
    		 66 66

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    NBI-1065845 1 mg
    Reporting group description
    		 -

    Reporting group title
    NBI-1065845 3 mg
    Reporting group description
    		 -

    Primary: Total Montgomery-Asberg Depression Rating Scale (MADRS) Score Least-Squares Mean Treatment Difference in Change from Baseline to Day 28

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    End point title
    		 Total Montgomery-Asberg Depression Rating Scale (MADRS) Score Least-Squares Mean Treatment Difference in Change from Baseline to Day 28
    End point description
    The least squares mean difference in change from baseline in the total MADRS score at Day 28 between each dose of NBI-1065845 and placebo are presented. A decrease in MADRS score indicated a decrease in the severity of depressive symptoms. Full analysis set included all randomized participants.
    End point type
    Primary
    End point timeframe
    Baseline to Day 28
    End point values
    		 Placebo NBI-1065845 1 mg NBI-1065845 3 mg
    Number of subjects analysed
    91 [1]
    45
    47
    Units: units on a scale
        least squares mean (confidence interval 95%)
    9999 (9999 to 9999)
    -4.3 (-7.8 to -0.8)
    -3.0 (-6.4 to 0.4)
    Notes
    [1] - No values are expected for LS mean difference for placebo arm (indicated as 9999).
    Statistical analysis title
    		 NBI-1065845 1 mg
    Statistical analysis description
    NBI-1065845 1 mg - Placebo
    Comparison groups
    Placebo v NBI-1065845 1 mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0159
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 NBI-1065845 3 mg
    Statistical analysis description
    NBI-1065845 3 mg - Placebo
    Comparison groups
    Placebo v NBI-1065845 3 mg
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0873
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Total MADRS Score Least-Squares Mean Treatment Difference in Change from Baseline to Day 56

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    End point title
    		 Total MADRS Score Least-Squares Mean Treatment Difference in Change from Baseline to Day 56
    End point description
    The least squares mean difference in change from baseline in the total MADRS score at Day 56 between each dose of NBI-1065845 and placebo are presented. A decrease in MADRS score indicated a decrease in the severity of depressive symptoms. Full analysis set included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 56
    End point values
    		 Placebo NBI-1065845 1 mg NBI-1065845 3 mg
    Number of subjects analysed
    79 [2]
    39
    40
    Units: units on a scale
        least squares mean (confidence interval 95%)
    9999 (9999 to 9999)
    -7.5 (-12.1 to -2.9)
    -3.6 (-8.0 to 0.8)
    Notes
    [2] - No values are expected for LS mean difference for placebo arm (indicated as 9999).
    Statistical analysis title
    		 NBI-1065845 1 mg
    Statistical analysis description
    NBI-1065845 1 mg - Placebo
    Comparison groups
    Placebo v NBI-1065845 1 mg
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 NBI-1065845 3 mg
    Statistical analysis description
    NBI-1065845 3 mg - Placebo
    Comparison groups
    Placebo v NBI-1065845 3 mg
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1082
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through Day 70
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    NBI-1065845 1 mg
    Reporting group description
    		 -

    Reporting group title
    NBI-1065845 3 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo NBI-1065845 1 mg NBI-1065845 3 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (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 NBI-1065845 1 mg NBI-1065845 3 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 91 (23.08%)
    9 / 45 (20.00%)
    8 / 47 (17.02%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 91 (8.79%)
    5 / 45 (11.11%)
    2 / 47 (4.26%)
         occurrences all number
    8
    8
    5
    Somnolence
         subjects affected / exposed
    3 / 91 (3.30%)
    3 / 45 (6.67%)
    0 / 47 (0.00%)
         occurrences all number
    3
    3
    0
    Dizziness
         subjects affected / exposed
    5 / 91 (5.49%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    5
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    5
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 45 (2.22%)
    3 / 47 (6.38%)
         occurrences all number
    2
    1
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 91 (5.49%)
    2 / 45 (4.44%)
    3 / 47 (6.38%)
         occurrences all number
    6
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2021
    Global amendment 1.0
    24 Sep 2021
    Global amendment 2.0
    09 Jun 2022
    Global amendment 3.0
    19 Nov 2022
    Global amendment 4.0

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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