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    Clinical Trial Results:
    A phase IIa study of GR3027 in patients with idiopathic hypersomnia (IH) involving an open-label part to assess safety, tolerability and pharmacokinetics (PK) of a single oral GR3027 dose in female patients and a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.

    Summary
    EudraCT number
    2017-002127-16
    Trial protocol
    FI   DK   SE  
    Global end of trial date
    19 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Nov 2019
    First version publication date
    03 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCAB-CT-03
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Umecrine Cognition AB
    Sponsor organisation address
    Fogdevreten 2, Solna, Sweden, 171 65
    Public contact
    Chief Executive Officer, Umecrine Cognition AB, 46 852484484, magnus.doverskog@umecrine.com
    Scientific contact
    Chief Executive Officer, Umecrine Cognition AB, 46 852484484, magnus.doverskog@umecrine.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
    12 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part A: The primary objective is to assess the safety and tolerability of GR3027 after a single oral dose of GR3027 in female patients with IH. Part B: The primary objective is to assess the safety and tolerability of GR3027 after multiple dose administration in patients with IH.
    Protection of trial subjects
    The protocol and the statement of informed consent were approved in the respective countries by an Independent Ethics Committee (IEC) prior to each centre's initiation. The trial was conducted in accordance with the Declaration of Helsinki and its revisions as well as with the valid local and national law(s), with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (GCP) (E6) issued in July 1996, and with the Commission Directives 2001/20/EC, 2005/28/EC and 2001/83/EC. Written Informed Consent was received from all subjects prior to enrolment into the trial, as dictated by the Declaration of Helsinki.
    Background therapy
    None
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Sep 2017
    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
    Sweden: 2
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Finland: 5
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment was initiated in Sept 2017 and was done simultaneously in FI, DK and SE

    Pre-assignment
    Screening details
    Female patients 18 to 55 years with a diagnosis of IH and with no current treatment for hypersomnolence disorder were enrolled in the study. There was a wash-out period of 14 days before randomization to study treatment.

    Period 1
    Period 1 title
    Overall study (overall period part B)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    The investigators, staff at the trial sites, trial monitors, and data analysis/management personnel were blinded to the subject assignment in order to ensure that information that could potentially bias handling of data was not disclosed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sequence: GR3027-Placebo
    Arm description
    Randomized subjects received GR3027 in the first study period (Day 1-14) and placebo in the second study period (Day 1-14). There was a 7 days wash-out period between study treatments.
    Arm type
    Experimental

    Investigational medicinal product name
    GR3027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    8 capsules received twice daily for 14 days

    Investigational medicinal product name
    GR3027 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    8 capsules twice daily for 14 days

    Arm title
    Sequence: Placebo-GR3027
    Arm description
    Randomized subjects received Placebo in the first study period (Day 1-14) and GR3027 in the second study period (Day 1-14). There was a 7 days wash-out period between study treatments.
    Arm type
    Experimental

    Investigational medicinal product name
    GR3027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    8 capsules of 80 mg twice daily for 14 days

    Investigational medicinal product name
    GR3027 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    8 capsules twice daily for 14 days

    Number of subjects in period 1
    Sequence: GR3027-Placebo Sequence: Placebo-GR3027
    Started
    4
    6
    Completed
    4
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence: GR3027-Placebo
    Reporting group description
    Randomized subjects received GR3027 in the first study period (Day 1-14) and placebo in the second study period (Day 1-14). There was a 7 days wash-out period between study treatments.

    Reporting group title
    Sequence: Placebo-GR3027
    Reporting group description
    Randomized subjects received Placebo in the first study period (Day 1-14) and GR3027 in the second study period (Day 1-14). There was a 7 days wash-out period between study treatments.

    Reporting group values
    Sequence: GR3027-Placebo Sequence: Placebo-GR3027 Total
    Number of subjects
    4 6 10
    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
    Patients aged 18-55 were enrolled in the study
    Units: years
        arithmetic mean (standard deviation)
    28.5 ± 5.4 32.2 ± 7.0 -
    Gender categorical
    Males and females aged 18-55 were enrolled in the study
    Units: Subjects
        Female
    1 4 5
        Male
    3 2 5

    End points

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    End points reporting groups
    Reporting group title
    Sequence: GR3027-Placebo
    Reporting group description
    Randomized subjects received GR3027 in the first study period (Day 1-14) and placebo in the second study period (Day 1-14). There was a 7 days wash-out period between study treatments.

    Reporting group title
    Sequence: Placebo-GR3027
    Reporting group description
    Randomized subjects received Placebo in the first study period (Day 1-14) and GR3027 in the second study period (Day 1-14). There was a 7 days wash-out period between study treatments.

    Subject analysis set title
    GR3027 (Full Analysis Set)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set included all subjects who were randomized and received study treatment.

    Subject analysis set title
    Placebo (Full Analysis Set)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set included all subjects imho were randomized and received study treatment.

    Primary: ESS

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    End point title
    ESS
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to end of study treatment period (14 days)
    End point values
    GR3027 (Full Analysis Set) Placebo (Full Analysis Set)
    Number of subjects analysed
    10
    10
    Units: Minutes
        least squares mean (confidence interval 95%)
    -0.71 (-2.21 to 0.79)
    -0.75 (-2.27 to 0.77)
    Statistical analysis title
    Mixed model analysis
    Statistical analysis description
    The mixed model analysis for ESS included baseline as a fixed effect. No other baseline covariates were adjusted for in the model. The significance level was not adjusted for multiple inferential tests, and type I error was therefore not be controlled, which is considered acceptable for exploratory efficacy evaluations. P-values below 0.05 were considered nominally statistically significant.
    Comparison groups
    GR3027 (Full Analysis Set) v Placebo (Full Analysis Set)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    ≤ 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.27
         upper limit
    2.36
    Notes
    [1] - P-values below 0.05 were considered nominally statistically significant.

    Primary: MWT

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    End point title
    MWT
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to end of study treatment (14 days)
    End point values
    GR3027 (Full Analysis Set) Placebo (Full Analysis Set)
    Number of subjects analysed
    10
    10
    Units: Minutes
        least squares mean (confidence interval 95%)
    0.28 (-3.18 to 3.74)
    -3.35 (-6.82 to 0.11)
    Statistical analysis title
    Mixed model analysis
    Statistical analysis description
    The mixed model analyses for MWT included baseline as a fixed effect. No other baseline covariates were adjusted for in the model.The significance level was not adjusted for multiple inferential tests, and type I error was therefore not be controlled, which is considered acceptable for exploratory efficacy evaluations. P-values below 0.05 were considered nominally statistically significant.
    Comparison groups
    GR3027 (Full Analysis Set) v Placebo (Full Analysis Set)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    ≤ 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    3.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.76
         upper limit
    8.03
    Notes
    [2] - P-values below 0.05 were considered nominally statistically significant.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study treatment at Day 1, up to 14 days after end of study treatment in period 2
    Adverse event reporting additional description
    An adverse event (AE) was any untoward medical occurrence in a subject administered the study treatment (GR3027 or placebo) which did not necessarily have a causal relationship with the study treatments
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    GR3027
    Reporting group description
    Randomized subjects for the sequence GR3027 - Placebo received GR3027 in the first study period (Day 1-14) and placebo in the second study period Day 1-14. There was a 7 days wash-out period between treatments. Randomized subjects for the sequence Placebo - GR3027 received placebo in the first study period (Day 1-14) and GR3027 in the second study period Day 1-14. There was a 7 days wash-out period between treatments.

    Reporting group title
    Placebo
    Reporting group description
    Randomized subjects for the sequence GR3027 - Placebo received GR3027 in the first study period (Day 1-14) and placebo in the second study period Day 1-14. There was a 7 days wash-out period between treatments. Randomized subjects for the sequence Placebo - GR3027 received placebo in the first study period (Day 1-14) and GR3027 in the second study period Day 1-14. There was a 7 days wash-out period between treatments.

    Serious adverse events
    GR3027 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    GR3027 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    9 / 10 (90.00%)
    Investigations
    Heart rate increased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Body temperature increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Poor quality sleep
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2018
    Clarification and change of inclusion criteria
    14 Mar 2018
    Update of exclusion criteria

    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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