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    Clinical Trial Results:
    EFFECTS OF BENFOTIAMINE ON INTRAEPIDERMAL NERVE FIBER DENSITY (IENFD) AND DIABETIC NEUROPATHY IN SUBJECTS WITH SENSORIMOTOR DIABETIC POLYNEUROPATHY: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP PILOT STUDY OVER 12 MONTHS

    Summary
    EudraCT number
    		 2013-001058-85
    Trial protocol
    		 DE  
    Global end of trial date
    19 Oct 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Jul 2020
    First version publication date
    13 Dec 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    During QC check an inconsistency was identified to statistical report. Therefore correction is necessary.
    Summary report(s)
    		 Development Safety Update Report

    Trial information

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    Trial identification
    Sponsor protocol code
    WOE_2013_SB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01868191
    WHO universal trial number (UTN)
    		 U1111-1140-6958
    Sponsors
    Sponsor organisation name
    Woerwag Pharma GmbH & Co. KG
    Sponsor organisation address
    Calwer Strasse 7, Boeblingen, Germany, 71034
    Public contact
    Investigator , Priv.-Doz. Dr. med. Ovidiu Alin Stirban , stirban@web.de
    Scientific contact
    Investigator , Priv.-Doz. Dr. med. Ovidiu Alin Stirban , stirban@web.de
    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
    19 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of the present study was to assess before, as well as after 6 and 12 months following a therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density (an early marker of nerve damage) in 22 people with type 1 or 2 diabetes mellitus and diabetic sensorimotor polyneuropathy. The trial was prematurely terminated (25-Sept-2015), due to technical problems with analysis of primary end point (skin biopsy). Therefore, secondary endpoints were analysed as observed.
    Protection of trial subjects
    The trial was not initiated before the protocol and all other relevant documents according to German GCP Ordinance had been reviewed, and received favourable opinion from the local Independent Ethics Committee (IEC) and approval by the Competent Authority, respectively. Should a protocol amendment be made that needed IEC favourable opinion and/or authority approval, the changes in the protocol were not to be instituted until the amendment had been reviewed and received favourable opinion by the local IEC, and approval by the Competent Authority. A protocol amendment intended to eliminate an apparent immediate hazard to subjects could have been implemented immediately providing that the regulatory authority and IEC were notified as soon as possible and an approval would have been requested. The constitution of the IEC met the requirements of ICH GCP and of the participating country. The IEC performed all duties outlined by the requirements of ICH GCP and of the participating country. Prior to subject participation in the trial, written informed consent was obtained from each subject according to ICH GCP and to the regulatory and legal requirements of the participating country. Each signature was personally dated by each signatory and the informed consent and any additional subject information form retained by the investigator as part of the trial records. A signed copy of the informed consent and any additional subject information was given to each subject. The subject was informed that his/her personal trial-related data would be used in accordance with the local data protection law. The level of disclosure was also explained to the subject. The subject was informed that his / her medical records could be examined by authorised monitors or Clinical Quality Assurance auditors appointed by the sponsor, by appropriate IEC members, and by inspectors from regulatory authorities.
    Background therapy
    		 Benfotiamine 300 mg was approved on 23.06.2005 for the treatment or prophylaxis of clinical manifest vitamin B1 deficiency if a dietary supplementation is not effective. Though, benfotiamine is used for many years in the treatment of diabetic and alcoholic polyneuropathies.
    Evidence for comparator
    		 Placebo tablets were provided in a blinded manner by the Sponsor for the 12 months therapy.
    Actual start date of recruitment
    09 Sep 2013
    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
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from the patients of the Diabetes Schwerpunktpraxis Essen (Camillo-Sitte Platz 1, 45136 Essen) and all study-related activities took place there.

    Pre-assignment
    Screening details
    		 Participants were screened at visit 1 (baseline) to be able to include 22 patients with T1 or T2DM on a stable regimen of antidiabetic treatment with no possibility of therapy intensification, with DSP, between 18 and 75 years of age, with a BMI between 25 and 45 kg/m2, HbA1c ≤9.5 % .

    Period 1
    Period 1 title
    visit 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benfotiamine V1
    Arm description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benfotiamine 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet with 300 mg Benfotiamin (total daily dose: 600mg) visit 4 to visit 7 (9 months): 1x1 tablet with 300 mg Benfotiamin (total daily dose: 300mg)

    Arm title
    		 Placebo V1
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet placebo visit 4 to visit 7 (9 months): 1x1 tablet placebo

    Number of subjects in period 1
    		Benfotiamine V1 Placebo V1
    Started
    11
    11
    Completed
    11
    11
    Period 2
    Period 2 title
    visit 4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benfotiamine V4
    Arm description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benfotiamine 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet with 300 mg Benfotiamin (total daily dose: 600mg) visit 4 to visit 7 (9 months): 1x1 tablet with 300 mg Benfotiamin (total daily dose: 300mg)

    Arm title
    		 Placebo V4
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet placebo visit 4 to visit 7 (9 months): 1x1 tablet placebo

    Number of subjects in period 2
    		Benfotiamine V4 Placebo V4
    Started
    11
    11
    Completed
    11
    10
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1
    Period 3
    Period 3 title
    visit 5
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benfotiamine V5
    Arm description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for the 9 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benfotiamine 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet with 300 mg Benfotiamin (total daily dose: 600mg) visit 4 to visit 7 (9 months): 1x1 tablet with 300 mg Benfotiamin (total daily dose: 300mg)

    Arm title
    		 Placebo V5
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet placebo visit 4 to visit 7 (9 months): 1x1 tablet placebo

    Number of subjects in period 3
    		Benfotiamine V5 Placebo V5
    Started
    11
    10
    Completed
    11
    10
    Period 4
    Period 4 title
    Visit 7
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benfotiamine V7
    Arm description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benfotiamine 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet with 300 mg Benfotiamin (total daily dose: 600mg) visit 4 to visit 7 (9 months): 1x1 tablet with 300 mg Benfotiamin (total daily dose: 300mg)

    Arm title
    		 Placebo V7
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    visit 1 to visit 4 (3 months): 2x 1 tablet placebo visit 4 to visit 7 (9 months): 1x1 tablet placebo

    Number of subjects in period 4
    		Benfotiamine V7 Placebo V7
    Started
    11
    10
    Completed
    7
    7
    Not completed
    4
    3
         Adverse event, serious fatal
    1
    -
         prematurely termination of the trial
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benfotiamine V1
    Reporting group description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months

    Reporting group title
    Placebo V1
    Reporting group description
    		 Placebo

    Reporting group values
    		 Benfotiamine V1 Placebo V1 Total
    Number of subjects
    		 11 11 22
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 6 12
        From 65-84 years
    		 5 5 10
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.82 ± 7.04 62.36 ± 10.73 -
    Gender categorical
    Units: Subjects
        Female
    		 5 4 9
        Male
    		 6 7 13
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 33.98 ± 6.17 35.00 ± 5.63 -

    End points

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    End points reporting groups
    Reporting group title
    Benfotiamine V1
    Reporting group description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months

    Reporting group title
    Placebo V1
    Reporting group description
    		 Placebo
    Reporting group title
    Benfotiamine V4
    Reporting group description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months

    Reporting group title
    Placebo V4
    Reporting group description
    		 Placebo
    Reporting group title
    Benfotiamine V5
    Reporting group description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for the 9 months

    Reporting group title
    Placebo V5
    Reporting group description
    		 Placebo
    Reporting group title
    Benfotiamine V7
    Reporting group description
    		 Benfotiamine 600 mg/day for 3 months followed by benfotiamine 300 mg/day for 9 months

    Reporting group title
    Placebo V7
    Reporting group description
    		 Placebo

    Primary: Intraepidermal nerve fiber density

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    End point title
    		 Intraepidermal nerve fiber density [1]
    End point description
    This Endpoint was not analyzed as due to technical problems no values could be detected in skin biopsy samples. This was the reason for prematurely termination of the trial. No data are availible, at all.
    End point type
    Primary
    End point timeframe
    Visit 2 (baseline), visit 5 (6 months), visit 7 (12 months)
    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: This Endpoint was not analyzed as due to technical problems no values could be detected in skin biopsy samples. This was the reason for prematurely termination of the trial. There are no data available at all.
    End point values
    		 Benfotiamine V1 Placebo V1
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: fibres/ mm
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - This Endpoint was not analyzed as due to technical problems no values could be detected in biopsies
    [3] - This Endpoint was not analyzed as due to technical problems no values could be detected in biopsies
    No statistical analyses for this end point

    Secondary: MNSI questionnaire

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    End point title
    		 MNSI questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (visit 1),visit 4 (3 months), visit 5 (6 months) visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    11
    11
    11
    10
    11
    10
    7
    7
    Units: Points
        arithmetic mean (standard deviation)
    9.09 ± 2.12
    8.27 ± 2.28
    8.09 ± 3.27
    8.0 ± 2.79
    7.45 ± 2.91
    8.5 ± 2.51
    6.0 ± 2.94
    8.0 ± 3.06
    No statistical analyses for this end point

    Secondary: MNSI examination

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    End point title
    		 MNSI examination
    End point description
    End point type
    Secondary
    End point timeframe
    visit 1 (baseline), visit 4 (3 months), visit 5 (6 months) visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    11
    11
    11
    10
    11
    10
    7
    7
    Units: points
        arithmetic mean (standard deviation)
    3.41 ± 1.43
    3.32 ± 1.66
    3.27 ± 2.09
    3.60 ± 1.90
    3.14 ± 2.16
    3.10 ± 1.31
    2.21 ± 1.52
    3.00 ± 1.91
    No statistical analyses for this end point

    Secondary: mTCNS

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    End point title
    		 mTCNS
    End point description
    End point type
    Secondary
    End point timeframe
    visit 1 (baseline), visit 4 (3 months), visit 5 (6 months) visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    11
    11
    11
    10
    11
    10
    7
    7
    Units: points
        arithmetic mean (standard deviation)
    7.55 ± 3.36
    6.64 ± 1.63
    6.18 ± 2.96
    5.70 ± 1.16
    5.55 ± 3.17
    5.00 ± 2.05
    4.71 ± 2.98
    5.71 ± 1.50
    No statistical analyses for this end point

    Secondary: Advanced glycation end products

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    End point title
    		 Advanced glycation end products
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline for this parameter), visit 4 (3 months) visit 5 (6 months), visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    11
    11
    11
    10
    11
    10
    7
    7
    Units: Autofluorescence
        arithmetic mean (standard deviation)
    2.81 ± 0.44
    2.95 ± 0.95
    2.85 ± 0.49
    3.02 ± 0.85
    2.96 ± 0.53
    3.03 ± 1.07
    2.89 ± 0.34
    3.44 ± 1.15
    No statistical analyses for this end point

    Secondary: Quality of Life (Neuro-QoL)

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    End point title
    		 Quality of Life (Neuro-QoL)
    End point description
    End point type
    Secondary
    End point timeframe
    visit 1 (baseline), visit 4 (3 months), visit 5 (6 months), visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    11
    11
    11
    10
    11
    10
    7
    7
    Units: points
        arithmetic mean (standard deviation)
    35.18 ± 5.71
    35.64 ± 4.03
    34.82 ± 5.36
    36.10 ± 3.96
    33.91 ± 5.22
    32.90 ± 7.69
    32.57 ± 5.35
    29.14 ± 9.21
    No statistical analyses for this end point

    Secondary: Thiamine-Di-Phosphate (Vitamin B1)

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    End point title
    		 Thiamine-Di-Phosphate (Vitamin B1)
    End point description
    End point type
    Secondary
    End point timeframe
    visit 1 (baseline) visit 4 (3 months) visit 5 (6 months) visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    9
    10
    11
    10
    10
    9
    7
    7
    Units: microgramm/ l
        arithmetic mean (standard deviation)
    70.83 ± 34.86
    65.58 ± 12.51
    168.82 ± 23.42
    64.10 ± 10.16
    162.80 ± 20.63
    65.06 ± 15.24
    155.53 ± 40.66
    59.77 ± 14.17
    No statistical analyses for this end point

    Other pre-specified: Numerical Rating Scale - Pain

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    End point title
    		 Numerical Rating Scale - Pain
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Visit 1 (baseline) visit 4 (3 months) Visit 5 (6 months) visit 7 (12 months)
    End point values
    		 Benfotiamine V1 Placebo V1 Benfotiamine V4 Placebo V4 Benfotiamine V5 Placebo V5 Benfotiamine V7 Placebo V7
    Number of subjects analysed
    11
    11
    11
    10
    11
    10
    7
    7
    Units: points
        arithmetic mean (standard deviation)
    4.45 ± 1.51
    4.27 ± 2.35
    4.0 ± 1.94
    3.40 ± 2.51
    3.23 ± 2.48
    4.10 ± 1.29
    3.29 ± 2.50
    2.36 ± 2.21
    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 inclusion (visit 1) until end of the trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Benfotiamine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Benfotiamine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    2 / 11 (18.18%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Angiocardiogram
    Additional description: Event. Elective coronary angiography
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Coronary artery restenosis
    Additional description: Related Event: Early in-stent thrombosis after percutaneous myocardial revascularisation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
    Additional description: Related Event: Early in-stent thrombosis after percutaneous myocardial revascularisation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
    Additional description: Stroke
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (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
    		 Benfotiamine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 11 (45.45%)
    4 / 11 (36.36%)
    Investigations
    Blood glucose abnormal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Gait disturbance
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2014
    Investigator change

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Sep 2015
    Prematurely termination of the trial, as primary endpoint (skin biopsy) could not be analysed, due to technical reasons.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Small number of patients (pilot study); premature termination of the study, both limiting the interpretation of the trial. Furthermore neuropathic symptoms were not an entry criterion, therefore symptom intensity/severity was relatively low.
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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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