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    Clinical Trial Results:
    A randomised double-blind placebo-controlled trial of the safety and efficacy of ethosuximide 250mg capsules for the management of chemotherapy-induced painful peripheral neuropathy.

    Summary
    EudraCT number
    		 2008-004499-38
    Trial protocol
    		 GB  
    Global end of trial date
    09 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Sep 2016
    First version publication date
    28 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCR 3116
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Royal Marsden NHS Foundation Trust
    Sponsor organisation address
    Sutton, London, United Kingdom, Sm25pt
    Public contact
    Clinical R&D Office, Royal Marsden NHS Foundation Trust, 0044 2086613903,
    Scientific contact
    Clinical R&D Office, Chief Investigator, 0044 20878082856,
    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
    10 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    A randomised double-blind placebo-controlled trial of the safety and efficacy of ethosuximide for the management of chemotherapy-induced painful peripheral neuropathy. Primary outcome measure will be the reduction in average pain intensity from baseline to end-point as measure on a 0-10 numerical rating scale.
    Protection of trial subjects
    Trial was conducted in accordance with protocol. No additional measures were taken.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2011
    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 Kingdom: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    12
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult cancer patients with chemotherapy-induced painful peripheral neuropathy were eligible for consideration of entry to the CIN-E study. Inclusion criteria include: pain severity of ≥4/10 on a numerical rating scale, and pain duration of ≥4 weeks. Recruitment continued from March 2011 to July 2014.

    Pre-assignment
    Screening details
    		 No screen failures are reported.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ethosuximide
    Arm description
    		 Patients randomised to receive Ethosuximide
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ethosuximide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    250mg oral capsule. Dosage titrated to effect according to following schedule- Week 1- 250mg (250mg o.d.) Week 2- 500mg (250mg b.d.) Week 3- 750mg (250mg mane, 500mg nocte) Week 4- 1000mg (500mg b.d.) Week 5- 1500mg (750mg b.d.) Week 6- 1500mg (750mg b.d.)

    Arm title
    		 Placebo
    Arm description
    		 Patients randomised to receive placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The placebo was administered under an identical schedule to the active IMP, i.e. 250mg capsules titrated over 6 weeks.

    Number of subjects in period 1
    		Ethosuximide Placebo
    Started
    7
    8
    Completed
    0
    7
    Not completed
    7
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    5
    1
         Unsatisfactory response
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ethosuximide
    Reporting group description
    		 Patients randomised to receive Ethosuximide

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to receive placebo

    Reporting group values
    		 Ethosuximide Placebo Total
    Number of subjects
    		 7 8 15
    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)
    		 58.4 ± 10.5 52 ± 12.2 -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 7
        Male
    		 4 4 8
    Ethnicity
    Units: Subjects
        Caucasian
    		 5 5 10
        Non-caucasian
    		 2 3 5
    Oncological Diagnosis
    Units: Subjects
        Breast
    		 1 3 4
        Lower GI
    		 2 3 5
        Upper GI
    		 1 0 1
        Sarcoma
    		 1 0 1
        Gynaecological
    		 1 1 2
        Myeloma
    		 1 0 1
        Urinary Tract
    		 0 1 1
    Likely CIPN Causal Agent
    Units: Subjects
        Paclitaxel
    		 2 5 7
        Oxaliplatin
    		 3 3 6
        Bortezumab
    		 1 0 1
        Docetaxel
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Ethosuximide
    Reporting group description
    		 Patients randomised to receive Ethosuximide

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to receive placebo

    Primary: Reduction of pain intensity from baseline to end-point

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    End point title
    		 Reduction of pain intensity from baseline to end-point [1]
    End point description
    End point type
    Primary
    End point timeframe
    Measured at 6 weeks post randomisation.
    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: Statistical analysis was not performed because the trial was terminated early with only 15 of the required 44 patients recruited. In the experimental group, all participants were withdrawn before reaching the 6 week time-point so there was no data to analyse.
    End point values
    		 Ethosuximide Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Pain score, difference from baseline
        number (not applicable)
    Notes
    [2] - None of the participants randomised to the ethosuximide arm reached the week 6 evaluation point.
    [3] - The pain scores were recorded only individually- no analysis was done.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the point of randomisation until 3 months after last IMP dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Ethosuximide arm
    Reporting group description
    		 Participants that received treatment with Ethosuximide

    Reporting group title
    Placebo arm
    Reporting group description
    		 Participants randomised to receive placebo

    Serious adverse events
    		 Ethosuximide arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Neutropenic sepsis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ethosuximide arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    8 / 8 (100.00%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    4 / 7 (57.14%)
    5 / 8 (62.50%)
         occurrences all number
    5
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 7 (28.57%)
    3 / 8 (37.50%)
         occurrences all number
    2
    3
    Nausea
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 8 (25.00%)
         occurrences all number
    2
    2
    Insomnia
         subjects affected / exposed
    4 / 7 (57.14%)
    2 / 8 (25.00%)
         occurrences all number
    4
    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.
    The trial was terminated early, with only 15 of the 44 required patients recruited.
    For support, Contact us.
    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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