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    Clinical Trial Results:
    A Remote, Open-Label, Long-Term, Follow-up Study to Determine the Safety, Tolerability, and Efficacy of Rotigotine Transdermal System as Monotherapy in Adolescents With Restless Legs Syndrome

    Summary
    EudraCT number
    		 2021-003403-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2023
    First version publication date
    21 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RL0007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03992196
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS)
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    		 Background therapy as permitted in the protocol
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    03 Dec 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Regulatory reason
    Long term follow-up duration
    		 13 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    0
    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)
    10
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study started to enroll participants in December 2019 and concluded prematurely in September 2022. Study participants entered this study from the parent rotigotine study in adolescents (SP1006) (NCT03728933).

    Pre-assignment
    Screening details
    		 10 participants were screened and considered enrolled, but only 9 participants were treated. The 10th participant was lost to follow-up prior dosing and no Adverse events were reported for this participant. Participant Flow refers to the Enrolled Set.

    Period 1
    Period 1 title
    Enrollment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 No Treatment
    Arm description
    		 Participant signed the informed consent form but never received any study medication during the study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Rotigotine Final Dose 2 mg/24 h
    Arm description
    		 Participants in this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Rotigotine Final Dose 3 mg/24 h
    Arm description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		No Treatment Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Started
    1
    2
    7
    Completed
    0
    2
    7
    Not completed
    1
    0
    0
         lost to follow-up prior dosing
    1
    -
    -
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rotigotine Final Dose 2 mg/24 h
    Arm description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotigotine
    Investigational medicinal product code
    Neupro
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Arm title
    		 Rotigotine Final Dose 3 mg/24 h
    Arm description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotigotine
    Investigational medicinal product code
    Neupro
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Data cannot be reported for a single participant due to data protection/data privacy.
    Number of subjects in period 2 [2]
    		Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Started
    2
    7
    Completed
    2
    1
    Not completed
    0
    6
         Poor drug compliance withdrawn by team & sponsor
    -
    1
         PI's decision due to IMP non-compliance
    -
    1
         Withdrawal due to non-compliance
    -
    1
         Withdrawal by parent/guardian
    -
    2
         Protocol deviation
    -
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 10 study participants were screened and enrolled, but only 9 participants were treated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rotigotine Final Dose 2 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Reporting group title
    Rotigotine Final Dose 3 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Reporting group values
    		 Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h Total
    Number of subjects
    		 2 7 9
    Age Categorical
    Units: Participants
        Adolescents (12-17 years)
    		 2 7 9
    Sex: Female, Male
    Units: Participants
        Female
    		 2 2 4
        Male
    		 0 5 5

    End points

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    End points reporting groups
    Reporting group title
    No Treatment
    Reporting group description
    		 Participant signed the informed consent form but never received any study medication during the study.

    Reporting group title
    Rotigotine Final Dose 2 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Reporting group title
    Rotigotine Final Dose 3 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.
    Reporting group title
    Rotigotine Final Dose 2 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Reporting group title
    Rotigotine Final Dose 3 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Primary: Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal of study medication

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    End point title
    		 Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal of study medication [1]
    End point description
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. The Safety Set consisted of all participants who had at least one patch (rotigotine) applied.
    End point type
    Primary
    End point timeframe
    From Baseline until the Safety Follow-Up Visit (up to 14 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: No formal statistical hypothesis testing was planned due to early stopping of this study. Results were summarized in tables as descriptive statistics only.
    End point values
    		 Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Number of subjects analysed
    2
    7
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of participants with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Percentage of participants with treatment-emergent adverse events (TEAEs) [2]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. The Safety Set consisted of all participants who had at least one patch (rotigotine) applied.
    End point type
    Primary
    End point timeframe
    From Baseline until the Safety Follow-Up Visit (up to 14 Months)
    Notes
    [2] - 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: No formal statistical hypothesis testing was planned due to early stopping of this study. Results were summarized in tables as descriptive statistics only.
    End point values
    		 Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Number of subjects analysed
    2
    7
    Units: percentage of participants
        number (not applicable)
    100
    85.7
    No statistical analyses for this end point

    Secondary: Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9

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    End point title
    		 Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9
    End point description
    The Clinical Global Impressions Item 1 (Severity of Illness) score ranges from 0 to 7 as follows: 0=not assessed, 1=normal, not ill at all, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill. The CGI Item 1 was completed during an interview between the participant and the investigator or designee. A negative change from Baseline indicates improvement. The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. 99999 signifies that summary statistics are not reported for N<3 due to small sample size and participant identification issues.
    End point type
    Secondary
    End point timeframe
    Visit 9 (Month 12), compared to Baseline (in SP1006)
    End point values
    		 Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Number of subjects analysed
    2
    2
    Units: score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Changes from Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9

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    End point title
    		 Changes from Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
    End point description
    The RLS-6 Rating Scales was designed to assess severity of RLS and consisted of 6 subscales. The subscales assessed severity of symptoms at the following times of the day/evening: falling asleep, during the night, during the day at rest, and during the day when engaged in daytime activities (not at rest). In addition, the subscales assessed satisfaction with sleep and severity of daytime tiredness/sleepiness. Scores for each of the 6 subscales ranged from 0 (completely satisfied) to 10 (completely dissatisfied). The change from baseline was derived for each of the subscales and reported in this outcome measure. A negative change from Baseline indicates improvement. The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. 99999 signifies that summary statistics are not reported for N<3 due to small sample size and participant identification issues.
    End point type
    Secondary
    End point timeframe
    Visit 9 (Month 12), compared to Baseline (in SP1006)
    End point values
    		 Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Number of subjects analysed
    2
    2
    Units: score on a scale
    arithmetic mean (standard deviation)
        Satisfaction with sleep
    99999 ( 99999 )
    99999 ( 99999 )
        Severity: RLS symptoms at falling asleep
    99999 ( 99999 )
    99999 ( 99999 )
        Severity: RLS symptoms during the night
    99999 ( 99999 )
    99999 ( 99999 )
        Severity: RLS symptoms during the day - at rest
    99999 ( 99999 )
    99999 ( 99999 )
        Severity: RLS symptoms during the day-not at rest
    99999 ( 99999 )
    99999 ( 99999 )
        How tired or sleepy during the day
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9

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    End point title
    		 Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9
    End point description
    The IRLS consisted of 10 questions, each scored using a 5-point scale ranging from 0=not present to 4=very severe. The IRLS sum score was calculated by summing up the single scores of all applicable questions, i.e., the total sum score ranged from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms). A score between 31 and 40, indicates very severe RLS. A score between 21 and 30 indicates severe RLS. A score between 11 and 20 indicates moderate RLS. A score between 1 and 10 indicates mild RLS and a score of 0 means no RLS. A negative change from Baseline indicates improvement. The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. 99999 signifies that summary statistics are not reported for N<3 due to small sample size and participant identification issues.
    End point type
    Secondary
    End point timeframe
    Visit 9 (Month 12), compared to Baseline (in SP1006)
    End point values
    		 Rotigotine Final Dose 2 mg/24 h Rotigotine Final Dose 3 mg/24 h
    Number of subjects analysed
    2
    2
    Units: score on a scale
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline until the Safety Follow-Up Visit (up to 14 Months)
    Adverse event reporting additional description
    TEAEs: Events started during Treatment Period (TP) or within 30 days following end of TP(i.e.,on or after date of first patch application and within 30 days following date of last patch removal + 1 day),or events where intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Rotigotine Final Dose 3 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Reporting group title
    Rotigotine Final Dose 2 mg/24 h
    Reporting group description
    		 Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator’s assessment. At the end of the Maintenance Period, participants were down-titrated.

    Serious adverse events
    		 Rotigotine Final Dose 3 mg/24 h Rotigotine Final Dose 2 mg/24 h
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 2 (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: 5%
    Non-serious adverse events
    		 Rotigotine Final Dose 3 mg/24 h Rotigotine Final Dose 2 mg/24 h
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    2 / 2 (100.00%)
    Injury, poisoning and procedural complications
    Procedural dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site rash
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Application site erythema
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 2 (100.00%)
         occurrences all number
    2
    2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 2 (0.00%)
         occurrences all number
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 2 (50.00%)
         occurrences all number
    1
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Rash papular
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 2 (50.00%)
         occurrences all number
    1
    1
    COVID-19
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Suspected COVID-19
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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