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    Clinical Trial Results:
    A Double-Blind, Placebo-Controlled, Randomised Study to Assess the Durability of Effect and Safety of Nemolizumab for 24 Weeks in Subjects with Prurigo Nodularis

    Summary
    EudraCT number
    		 2021-003928-32
    Trial protocol
    		 AT   DE   BE   FR   PL  
    Global end of trial date
    11 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2024
    First version publication date
    02 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.06.SPR.203890
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05052983
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 117122
    Sponsors
    Sponsor organisation name
    Galderma S.A.
    Sponsor organisation address
    Zählerweg 10, Zug, Switzerland, 6300
    Public contact
    Clinical Trial Information Desk, Galderma S.A., ctacoordinator@galderma.com
    Scientific contact
    Clinical Trial Information Desk, Galderma S.A., ctacoordinator@galderma.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
    11 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in subjects with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (2019-004294-13).
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice (GCP) as required by the International Council for Harmonisation (ICH) guidelines. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 2022
    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
    Switzerland: 4
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Worldwide total number of subjects
    34
    EEA total number of subjects
    27
    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)
    22
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 14 study sites in 7 countries from 24 January 2022 to 11 September 2023.

    Pre-assignment
    Screening details
    		 A total of 34 subjects from LTE study RD.06.SPR.202699 (2019-004294-13) were enrolled and treated in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nemolizumab
    Arm description
    		 Subjects received either 1 (30 milligram [mg]) or 2 (2*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by interactive response technology (IRT).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CD14152
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg (1 injection) or 2*30mg (2 injections) of nemolizumab SC, Q4W.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received either 1 (30 mg) or 2 (2*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by IRT.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Nemolizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg (1 injection) or 2*30mg (2 injections) of placebo SC, Q4W.

    Number of subjects in period 1
    		Nemolizumab Placebo
    Started
    18
    16
    Completed
    14
    4
    Not completed
    4
    12
         Adverse event
    1
    -
         Lack of efficacy
    3
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nemolizumab
    Reporting group description
    		 Subjects received either 1 (30 milligram [mg]) or 2 (2*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by interactive response technology (IRT).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received either 1 (30 mg) or 2 (2*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by IRT.

    Reporting group values
    		 Nemolizumab Placebo Total
    Number of subjects
    		 18 16 34
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.9 ( 14.06 ) 59.1 ( 13.41 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 13 27
        Male
    		 4 3 7
    Ethnicity (NIH/ OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 13 15 28
        Unknown or Not Reported
    		 4 1 5
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 14 15 29
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 3 1 4

    End points

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    End points reporting groups
    Reporting group title
    Nemolizumab
    Reporting group description
    		 Subjects received either 1 (30 milligram [mg]) or 2 (2*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by interactive response technology (IRT).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received either 1 (30 mg) or 2 (2*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by IRT.

    Primary: Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria

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    End point title
    		 Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria
    End point description
    Time from baseline to relapse, defined as meeting at least 1 of the following criteria 1. Increase in (weekly average of the) Peak Pruritus Numerical Rating Scale (PP NRS) score greater than or equal to (>=)4 points from baseline 2. Increase in Investigator’s Global Assessment (IGA) score >=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication. Intent-to-treat (ITT) population included all randomised subjects. Here, “overall number of subjects analysed” signified subjects who were evaluable for this endpoint. Here, "99999" was used as a space filler and denotes that median and 95% CI were not evaluated due to insufficient number subject with relapse.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    18
    16
    Units: Days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    112.50 (84.00 to 161.00)
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.125
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.034
         upper limit
    		 0.462

    Secondary: Percentage of Subjects who Maintained Investigator Global Assessment (IGA) Success at Each Scheduled Visit

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    End point title
    		 Percentage of Subjects who Maintained Investigator Global Assessment (IGA) Success at Each Scheduled Visit
    End point description
    IGA was a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator reviewed the subject's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Treatment response/success was defined as 0 (clear) or 1 (almost clear). ITT population included all randomised subjects. Here, "n" included all subjects who were evaluated for this endpoint for the specified timepoint. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    18
    16
    Units: Percentage of Subjects
    number (not applicable)
        At week 4 (n=17,15)
    88.2
    86.7
        At week 8 (n=17,16)
    82.4
    81.3
        At week 12 (n=17,15)
    88.2
    53.3
        At week 16 (n=16,11)
    81.3
    27.3
        At week 20 (n=15,7)
    86.7
    57.1
        At week 24 (n=14,5)
    85.7
    60.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit

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    End point title
    		 Percentage of Subjects with Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit
    End point description
    Pruritus NRS is a scale used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a 11-point scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. ITT population included all randomised subjects. Here, "n" included all subjects who were evaluated for this endpoint for the specified timepoint. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    18
    16
    Units: Percentage of subjects
    number (not applicable)
        At week 4 (n=13,13)
    0
    0
        At week 8 (n= 13,14)
    0
    0
        At week 12 (n-=16,12)
    0
    16.7
        At week 16 (n=15,12)
    6.7
    33.3
        At week 20 (n=14,6)
    0
    33.3
        At week 24 (n=10,5)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to End of study (Week 32)
    Adverse event reporting additional description
    The safety population included all randomised subjects who receive at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Nemolizumab
    Reporting group description
    		 Subjects received either 1(30mg) or 2(2*30 mg) SC injection(s) of nemolizumab Q4W for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by IRT.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received either 1 (30 mg) or 2 (2*30 mg) SC injection(s) of placebo Q4W for a period of 24 weeks (with last injection at Week 20). Subjects received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699 (2019-004294-13), as assigned by IRT.

    Serious adverse events
    		 Nemolizumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (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
    Cerebral ischaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Nemolizumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 18 (61.11%)
    10 / 16 (62.50%)
    Vascular disorders
    Diabetic macroangiopathy
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Administration site erythema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Administration site reaction
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Aphonia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Peak expiratory flow rate decreased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Urinary lipids present
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Post procedural complication
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Extrasystoles
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    3
    3
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Seizure
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Dental caries
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Intertrigo
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Lichen planus
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Neurodermatitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Endocrine disorders
    Thyroid cyst
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Exostosis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Neck pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Synovial cyst
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    2 / 18 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    2
    3
    Cystitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Febrile infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Otitis media
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Pustule
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2022
    Following changes were made: 1)Updated planned sample size according to current enrollment projections. 2)Updated the introduction to include new nemolizumab ongoing studies and completion of PN Phase 3 pivotal study RD.06.SRE.203065. 3) Excluded clarification on double barrier method for Germany only; this was covered in a country-specific amendment (protocol version 3.0). 4)Excluded gabapentinoids alone as a prohibited therapy, as they are examples of prohibited anti-epileptics. 5) Added that a minimum 3-week interval must have occurred between doses of study drug for subjects who re-entered the LTE study. 6)Updated conditions for an interim analysis to optional (not mandatory) as it was most likely to be inconclusive due to small sample size. 7)Modified IB version from Version R11 to Version R14.

    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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