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    Clinical Trial Results:
    A 10-day prospective, single-center, double-blind, placebo-controlled, randomized study to evaluate safety, tolerability and pharmacokinetics of 600 mg b.i.d. oral doses of LM11A-31-BHS in healthy elderly volunteers

    Summary
    EudraCT number
    		 2018-001071-20
    Trial protocol
    		 ES  
    Global end of trial date
    21 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2021
    First version publication date
    07 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NSC18001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PharmatrophiX Inc.
    Sponsor organisation address
    1015 Monte Rosa Drive, Menlo Park, CA, United States, 94025
    Public contact
    CRO, NeuroScios GmbH, 0043 31324044412, nhelmberg@neuroscios.com
    Scientific contact
    Frank Longo, MD, PhD, PharmatrophiX Inc., 001 6507243172, frank@pharmatrophix.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
    26 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the safety and tolerability of 600 mg b.i.d. of LM11A-31-BHS (free base) administered orally to healthy elderly volunteers for a period of 10 days in comparison to placebo.
    Protection of trial subjects
    Trial specific stopping rules were set to protect the trial subjects. Dosing would have been stopped for all subjects and the trial terminated if any of the stopping rules had occured.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jan 2019
    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: 10
    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)
    5
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between January 22nd, 2019 and March 5th, 2019.

    Pre-assignment
    Screening details
    		 Screening had to be performed within three weeks prior to the baseline visit. There were 5 screening failures.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LM11A-31-BHS
    Arm description
    		 600 mg LM11A-31_BHS in the morning and in the evening (total daily dosage = 1200 mg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    LM11A-31-BHS
    Investigational medicinal product code
    LM11A-31-BHS
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules with 200 mg LM11A-31-BHS administered b.i.d. with approximately 240 mL of water

    Arm title
    		 Placebo
    Arm description
    		 600 mg placebo in the morning and in the evening (total daily dosage = 1200 mg)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules with 200 mg placebo administered b.i.d. with approximately 240 mL of water

    Number of subjects in period 1
    		LM11A-31-BHS Placebo
    Started
    8
    2
    Completed
    8
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LM11A-31-BHS
    Reporting group description
    		 600 mg LM11A-31_BHS in the morning and in the evening (total daily dosage = 1200 mg)

    Reporting group title
    Placebo
    Reporting group description
    		 600 mg placebo in the morning and in the evening (total daily dosage = 1200 mg)

    Reporting group values
    		 LM11A-31-BHS Placebo Total
    Number of subjects
    		 8 2 10
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 1 5
        From 65-84 years
    		 4 1 5
    Gender categorical
    Units: Subjects
        Female
    		 4 1 5
        Male
    		 4 1 5

    End points

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    End points reporting groups
    Reporting group title
    LM11A-31-BHS
    Reporting group description
    		 600 mg LM11A-31_BHS in the morning and in the evening (total daily dosage = 1200 mg)

    Reporting group title
    Placebo
    Reporting group description
    		 600 mg placebo in the morning and in the evening (total daily dosage = 1200 mg)

    Primary: To investigate the safety and tolerability of 600 mg b.i.d. of LM11A-31-BHS administered to healthy elderly volunteers for a period of 10 days in comparison to placebo

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    End point title
    		 To investigate the safety and tolerability of 600 mg b.i.d. of LM11A-31-BHS administered to healthy elderly volunteers for a period of 10 days in comparison to placebo [1]
    End point description
    End point type
    Primary
    End point timeframe
    continuouse until day 11, last dose is given in the morning of day 10
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Because of the nature of the study, the results were only descriptively summerized.
    End point values
    		 LM11A-31-BHS Placebo
    Number of subjects analysed
    8
    2
    Units: drug related adverse events
        mild drug related adverse events
    4
    0
        moderate drug related adverse events
    0
    0
        severe drug related adverse events
    0
    0
        drug related serious adverse events
    0
    0
    No statistical analyses for this end point

    Secondary: To investigate the systemic pharmacokinetics of 600 mg b.i.d. doses of LM11A-31-BHS administered orally for a period of 10 days in healthy erlderly volunteers

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    End point title
    		 To investigate the systemic pharmacokinetics of 600 mg b.i.d. doses of LM11A-31-BHS administered orally for a period of 10 days in healthy erlderly volunteers
    End point description
    End point type
    Secondary
    End point timeframe
    day 1, 2, 5, 8, 10 and 11 with several timepoints on day 1 and 10
    End point values
    		 LM11A-31-BHS Placebo
    Number of subjects analysed
    8
    2
    Units: Cmax [ng/mL]
    arithmetic mean (standard deviation)
        day 1
    1271.61 ( 606.76 )
    0 ( 0 )
        day 10
    885.18 ( 522.75 )
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: To evaluate cerebrospinal fluid (CSF) levels of LM11A-31-BHS under the conditions of this trial

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    End point title
    		 To evaluate cerebrospinal fluid (CSF) levels of LM11A-31-BHS under the conditions of this trial
    End point description
    End point type
    Secondary
    End point timeframe
    several timepoints on day 10
    End point values
    		 LM11A-31-BHS Placebo
    Number of subjects analysed
    8
    2
    Units: Cmax [ng/mL]
        arithmetic mean (standard deviation)
    56.00 ( 24.54 )
    0 ( 0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    January 22nd, 2019 - March 21st, 2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    LM11A-31-BHS
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 LM11A-31-BHS Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LM11A-31-BHS Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    2 / 2 (100.00%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 8 (62.50%)
    0 / 2 (0.00%)
         occurrences all number
    7
    0
    Presyncope
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Diarrhea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 2 (100.00%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0

    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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