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    Clinical Trial Results:
    Phase IIa, double-blind, randomized, placebo-controlled study of the efficacy and safety of SOM3335 in Huntington`s disease (HD) patients with chorea movements.

    Summary
    EudraCT number
    		 2018-000203-16
    Trial protocol
    		 ES  
    Global end of trial date
    22 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2022
    First version publication date
    06 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOMCT02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03575676
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SOM Innovation Biotech SA
    Sponsor organisation address
    Baldiri Reixac, 4, Barcelona, Spain, 08028
    Public contact
    Clinical Project Leader, SOM Biotech, 34 934020150, ferre@sombiotech.com
    Scientific contact
    Clinical Project Leader, SOM Biotech, 34 934020150, ferre@sombiotech.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
    22 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether SOM3355 reduces chorea movements associated with Huntington's Disease.
    Protection of trial subjects
    Inclusion and exclusion criteria were carefully selected to include only those patients that could benefit from the investigational medicinal product without taking any risk related to their concomitant pathologies and medications. Subject withdrawal criteria were also defined so the investigator may discontinue any patient from the study if he/she considers it necessary for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Aug 2018
    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
    Spain: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    30
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between August 2018 and February 2019 at four sites in Spain.

    Pre-assignment
    Screening details
    		 The main inclusion criteria were having a Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score ≥8 and Total Functional Capacity (TFC) score ≥4. The exclusion criteria were being co-administered VMAT2 inhibitors, antihypertensive medications, monoamine oxidase inhibitors, or typical neuroleptics.

    Period 1
    Period 1 title
    Arm A and Arm B in cross-over (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    Study drug was manufactured to be blind.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A (sequence active drug-placebo)
    Arm description
    		 Administration of SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, SOM3355 100mg BID for 6 weeks, and placebo BID for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SOM3355 100mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    SOM3355 100mg capsules were orally administered twice daily (BID).

    Investigational medicinal product name
    SOM3355 200mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    SOM3355 200mg capsules were orally administered twice daily (BID).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Ocular use
    Dosage and administration details
    Placebo capsules were orally administered twice daily (BID).

    Arm title
    		 Arm B (sequence placebo-active drug)
    Arm description
    		 Administration of placebo BID for 6 weeks, SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, and SOM3355 100mg BID for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SOM3355 100mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    SOM3355 100mg capsules were orally administered twice daily (BID).

    Investigational medicinal product name
    SOM3355 200mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    SOM3355 200mg capsules were orally administered twice daily (BID).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Ocular use
    Dosage and administration details
    Placebo capsules were orally administered twice daily (BID).

    Number of subjects in period 1
    		Arm A (sequence active drug-placebo) Arm B (sequence placebo-active drug)
    Started
    16
    16
    Completed
    14
    13
    Not completed
    2
    3
         Sponsor's decision
    -
    1
         Adverse event, non-fatal
    1
    2
         Non-compliance with study drug
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A and Arm B in cross-over
    Reporting group description
    		 Safety Population (SP): All patients who received at least one dose of study treatment.

    Reporting group values
    		 Arm A and Arm B in cross-over Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.0 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    Arm A (sequence active drug-placebo)
    Reporting group description
    		 Administration of SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, SOM3355 100mg BID for 6 weeks, and placebo BID for 6 weeks.

    Reporting group title
    Arm B (sequence placebo-active drug)
    Reporting group description
    		 Administration of placebo BID for 6 weeks, SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, and SOM3355 100mg BID for 6 weeks.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol (PP) population consisted of all randomized patients who completed V0-V3 study visits and did not have major protocol deviations.

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    Improvement in any active drug period in Total Maximal Chorea (TMC) score of at least 2 points compared with placebo period
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Arm A (sequence active drug-placebo) Arm B (sequence placebo-active drug) Per Protocol Population
    Number of subjects analysed
    14
    14
    28
    Units: % subjects reaching the primary endpoint
        number (not applicable)
    57.1
    57.1
    57.1
    Statistical analysis title
    		 Primary efficacy analysis
    Comparison groups
    Arm A (sequence active drug-placebo) v Arm B (sequence placebo-active drug) v Per Protocol Population
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    27 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 All patients who had received at least one dose of study treatment were included in the safety population (SP).

    Serious adverse events
    		 Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Delirium
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 32 (75.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    7
    Hand fracture
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Vascular disorders
    Hypotension
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Hypokinesia
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    5
    Irritability
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    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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    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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