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    Clinical Trial Results:
    The HAM Ciclosporin Study: An observational trial of therapy in early or progressing HAM/TSP

    Summary
    EudraCT number
    		 2006-002031-24
    Trial protocol
    		 GB  
    Global end of trial date
    29 Jan 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2019
    First version publication date
    16 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HAM005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00773292
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensingston Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Prof Graham Taylor, Imperial College London, +44 020 3312 1521, g.p.taylor@imperial.ac.uk
    Scientific contact
    Prof Graham Taylor, Imperial College London, +44 020 3312 1521, g.p.taylor@imperial.ac.uk
    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
    24 Jan 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine in an open, pilot, proof of principle study whether ciclosporin A improves the clinical measures of patients with ‘early’ or ‘progressing’ ‘definite’ HAM/TSP
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    6
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients attended to National Centre for Human Retrovirology at St Mary’s Hospital, London.

    Pre-assignment
    Screening details
    		 Eligible patients had definite HAM/TSP, as defined by ‘Belem criteria’ and either had developed first symptoms within the last two years or had progressive disease, as defined by 50% documented deterioration in 10 m timed walk over the preceding three months.

    Period 1
    Period 1 title
    Pre - Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participants
    Arm description
    		 4 weeks treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    None
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment in the pre-treatment period

    Number of subjects in period 1
    		All participants
    Started
    7
    Completed
    7
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participants
    Arm description
    		 48 weeks treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ciclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration

    Number of subjects in period 2
    		All participants
    Started
    7
    Completed
    5
    Not completed
    2
         Adverse event, non-fatal
    1
         Lack of efficacy
    1
    Period 3
    Period 3 title
    Post treatment follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participants
    Arm description
    		 24 weeks treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    None
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment in the pre-treatment period

    Number of subjects in period 3
    		All participants
    Started
    5
    Completed
    7
    Joined
    2
         stayed on the study,even they didnt finish treatme
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pre - Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Pre - Treatment Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 50 (40 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 4 weeks treatment
    Reporting group title
    All participants
    Reporting group description
    		 48 weeks treatment
    Reporting group title
    All participants
    Reporting group description
    		 24 weeks treatment

    Primary: Number of Patient With Lack of Objective Clinical Improvement

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    End point title
    		 Number of Patient With Lack of Objective Clinical Improvement [1]
    End point description
    Lack of objective clinical improvement after three months of therapy. Objective improvement was defined as any of the following comparing baseline measurements to 12, 24 and 48 weeks: i) one point decrease in the IPEC 1 scale (Instituto de Pesquisa Clínica Evandro Chagas), ii) >30% improvement in 10 m timed walk, iii) visual analogue pain score reduced by >2 points, iv) reduction of frequency or nocturia by greater than one or reduction of residual volume by more than 10% at two consecutive visits. Proof of concept study and therefore outcomes report is descriptive only. No statistical test appropriate.
    End point type
    Primary
    End point timeframe
    12 month
    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: Proof of concept study and therefore outcomes report is descriptive only. No statistical test appropriate. Please see attached article.
    End point values
    		 All participants
    Number of subjects analysed
    7
    Units: number of participant
    0
    No statistical analyses for this end point

    Secondary: Changes in Clinical Outcome Measures, Time Walk at 12 Weeks Compared to Baseline

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    End point title
    		 Changes in Clinical Outcome Measures, Time Walk at 12 Weeks Compared to Baseline
    End point description
    Change in the time taken to walk 10 meters 0 - 12 weeks compared with baseline. A timed walk rank was created to take into account the use of walking aids. Timed walk rank was calculated by ranking the time to walk 10 meters over all patients and visits, in the following order (highest/worst score to lowest/best score): unable to walk; able to walk, but not able to complete 10 meters (ranked on distance walked and time taken); able to walk 10 meters with a bilateral aid; able to walk 10 meters with a unilateral aid; able to walk 10 meters unaided (all ranked on time taken). Decrease in score means improvement.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 All participants
    Number of subjects analysed
    7
    Units: score
        geometric mean (standard deviation)
    -7 ± 5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    72 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 4 weeks treatment

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/2272010
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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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