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    Clinical Trial Results:
    Randomized double blind parallel groups sequential, placebo controlled, trial assessing the efficacy and safety of BP1.4979 in Resteless Legs Syndrome (RLS).

    Summary
    EudraCT number
    		 2013-004884-30
    Trial protocol
    		 FR  
    Global end of trial date
    17 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P13-04/BP1.4979
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03345953
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bioprojet Pharma
    Sponsor organisation address
    9 rue Rameau, Paris, France, 75002
    Public contact
    Bioprojet clinical departement, Bioprojet Pharma, 0033 147036633, contact@bioprojet.com
    Scientific contact
    Bioprojet clinical departement, Bioprojet Pharma, 0033 147036633, contact@bioprojet.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
    05 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess in RLS patients the efficacy and the safety profile of BP1.4979 15 mg BID.
    Protection of trial subjects
    The study was conducted in accordance with the Ethical principles stated in the Declaration of Helsinki (Tokyo, October 2013) and the French law n° 2004-806, August 9th, 2004 relative to public health law as well as the May 1996 International Council on Harmonisation(ICH) Guidelines. The study was also conducted in accordance with International Guidelines on Good Clinical Practices (GCP) and Standard Operating Procedures (SOP) for clinical investigation and documentation in force at Bioprojet Pharma. The study was monitored by Bioprojet Pharma who regularly checked compliance with the protocol, compared selected key data in the CRF with its source data, and verified Drug Accountability and Informed Consent signatures.
    Background therapy
    		 Patients had to stop any medication prescribed for the treatment of their Restless Legs Syndrome (RLS), any drug associated with the development or the worsening of their RLS (e.g., antidepressants, antipsychotics and dopamine antagonists, etc..) and any other medication that may have caused sedation or negatively impacted with the study drug activity (e.g., sedatives, hypnotics, steroids).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2018
    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
    France: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    15
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in France from February 2018 until mid of March 2020.

    Pre-assignment
    Screening details
    		 A total of 67 patients were screened. Twenty-nine (29) out of the 67 were randomized to receive either the activie drug, BP1.4979 (13 patients) or the placebo (19 patients).

    Pre-assignment period milestones
    Number of subjects started
    		 29
    Number of subjects completed
    		 29

    Period 1
    Period 1 title
    Double-blind period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The placebo tablets were identical in appearance to the BP1.4979 tablets, and patients / investigators / site staff / other contributors remained blinded to the treatment randomization code.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BP1.4979 treatment arm (Double-blind)
    Arm description
    		 Patients with Restless Legs Syndrome (RLS) were treated with BP1.4979 15 mg tablets twice a day from randomization until end of the Double-Blind period (i.e., for 2 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BP1.4979
    Investigational medicinal product code
    BP1.4979
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were to take 2 tablets of 15 mg BP1.4979 per day: one during lunch and one in the evening during dinner with a glass of water from randomization until end of Double-Blind period.

    Arm title
    		 Placebo arm (Double-Blind)
    Arm description
    		 Patients with Restless Legs Syndrome (RLS) were treated with placebo tablets twice a day from randomization until end of the Double-Blind period (i.e., for 2 weeks).
    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
    Patients were to take 2 tablets of placebo per day: one during lunch and one in the evening during dinner with a glass of water from randomization until end of Double-Blind period.

    Number of subjects in period 1
    		BP1.4979 treatment arm (Double-blind) Placebo arm (Double-Blind)
    Started
    13
    16
    Completed
    13
    15
    Not completed
    0
    1
         Lack of efficacy
    -
    1
    Period 2
    Period 2 title
    Single-Blind
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 Placebo arm (Single-Blind)
    Arm description
    		 Patients who completed the Double-Blind period were to continue in the study for a 1-week single-blind period under placebo treatment.
    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
    Patients were to take 2 tablets of placebo per day: one during lunch and one in the evening during dinner with a glass of water for one week from the end of Double-Blind period until the end of study.

    Number of subjects in period 2
    		Placebo arm (Single-Blind)
    Started
    28
    Completed
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BP1.4979 treatment arm (Double-blind)
    Reporting group description
    		 Patients with Restless Legs Syndrome (RLS) were treated with BP1.4979 15 mg tablets twice a day from randomization until end of the Double-Blind period (i.e., for 2 weeks).

    Reporting group title
    Placebo arm (Double-Blind)
    Reporting group description
    		 Patients with Restless Legs Syndrome (RLS) were treated with placebo tablets twice a day from randomization until end of the Double-Blind period (i.e., for 2 weeks).

    Reporting group values
    		 BP1.4979 treatment arm (Double-blind) Placebo arm (Double-Blind) Total
    Number of subjects
    		 13 16 29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 8 15
        From 65-84 years
    		 6 8 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.27 ± 13.63 58.20 ± 17.52 -
    Gender categorical
    Units: Subjects
        Female
    		 5 8 13
        Male
    		 8 8 16

    End points

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    End points reporting groups
    Reporting group title
    BP1.4979 treatment arm (Double-blind)
    Reporting group description
    		 Patients with Restless Legs Syndrome (RLS) were treated with BP1.4979 15 mg tablets twice a day from randomization until end of the Double-Blind period (i.e., for 2 weeks).

    Reporting group title
    Placebo arm (Double-Blind)
    Reporting group description
    		 Patients with Restless Legs Syndrome (RLS) were treated with placebo tablets twice a day from randomization until end of the Double-Blind period (i.e., for 2 weeks).
    Reporting group title
    Placebo arm (Single-Blind)
    Reporting group description
    		 Patients who completed the Double-Blind period were to continue in the study for a 1-week single-blind period under placebo treatment.

    Primary: PLMS index (Periodic Limb Movements per hour of Sleep)

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    End point title
    		 PLMS index (Periodic Limb Movements per hour of Sleep)
    End point description
    The PLMS index (Periodic Limb Movements per hour of Sleep) was evaluated by polysomnography (PSG) at baseline (i.e., prior to randomization) and at the end of the double-blind period. The change in PLMS index from baseline to the end of the double-blind period was measured in the ITT population.
    End point type
    Primary
    End point timeframe
    The PLMS index was evaluated at baseline (prior to randomization) and at the end of the Double-Blind period (i.e., V2 and V3).
    End point values
    		 BP1.4979 treatment arm (Double-blind) Placebo arm (Double-Blind)
    Number of subjects analysed
    13
    16
    Units: Number of leg movements per hour
    arithmetic mean (standard deviation)
        PLMS index
    -19.57 ± 12.62
    -9.01 ± 18.01
    Statistical analysis title
    		 Adjusted treatment effect
    Comparison groups
    BP1.4979 treatment arm (Double-blind) v Placebo arm (Double-Blind)
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19

    Secondary: IRLSRS (International Restless Legs Syndrome Rating Scale) score

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    End point title
    		 IRLSRS (International Restless Legs Syndrome Rating Scale) score
    End point description
    The IRLSRS is a 10-question scale on RLS symptoms, each rated from 0 (none) to 4 (very severe). An overall score of 31-40 points was classified as very severe, 21-30 points as severe, 11-20 points as moderate, 1-10 points as mild, and 0 points as none. The IRLSRS score was evaluated at baseline (i.e., prior to randomization) and the end of the Double-Blind period. The change in International Restless Legs Syndrome Rating Scale (IRLSRS) score from baseline to the end of the Double-Blind period was measured in the ITT population.
    End point type
    Secondary
    End point timeframe
    The IRLSRS score was evaluated at baseline (prior to randomization) and at the end of the Double-Blind period (i.e., V2 and V3).
    End point values
    		 BP1.4979 treatment arm (Double-blind) Placebo arm (Double-Blind)
    Number of subjects analysed
    13
    16
    Units: Score
    arithmetic mean (standard deviation)
        IRLSRS score
    -7.46 ± 8.66
    -4.56 ± 5.69
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of reporting AEs extended from the time the patient gave informed consent until the last follow-up visit of the patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    BP1.4979 Treatment Arm
    Reporting group description
    		 -

    Reporting group title
    Placebo Treatment Arm
    Reporting group description
    		 -

    Serious adverse events
    		 BP1.4979 Treatment Arm Placebo Treatment Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 BP1.4979 Treatment Arm Placebo Treatment Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 13 (30.77%)
    8 / 16 (50.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Balance disorder
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Infections and infestations
    Bonchitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    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? Yes
    Date
    Interruption
    Restart date
    17 Mar 2020
    From June 2019, it was apparent that the recruitment of the trial was difficult, mainly due to the necessity of hospitalizing patients for polysomnography needed for reporting the main PLMS score. For one year, the recruitment did not increase, and from March 2020, the COVID-19 crisis annihilated any hope for further accrual. It was decided to anticipate the statistical analysis of the second GST look at the current sample size (n=29). Consecutively to the second look, a premature stop of the study was decided for significant result of the main endpoint by Bioprojet Pharma on 29 April 2020.
    -

    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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