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    Clinical Trial Results:
    An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

    Summary
    EudraCT number
    2017-001590-16
    Trial protocol
    DE   IT  
    Global end of trial date
    13 Dec 2019

    Results information
    Results version number
    v2(current)
    This version publication date
    03 Mar 2021
    First version publication date
    27 Dec 2020
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    Additional data added for one endpoint.

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-563
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03391765
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    13 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was a Phase 2, randomized, double-blind, multiple-dose, multicenter, long-term extension of NCT02985879 (Study M15-562) in subjects with progressive supranuclear palsy (PSP). Those who completed the 52-week Treatment Period in Study M15-562 and met all entry criteria were eligible for enrollment into this study. This study planned for a Treatment Period of up to 5 years and a post-treatment follow-up visit approximately 20 weeks after the last dose of study drug (including participants who prematurely discontinued treatment). All participants received ABBV-8E12 as follows: those who received placebo in Study M15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received ABBV-8E12 at a dose of either 2000 or 4000 mg in Study M15-562 continued on the same dose in this study. This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.
    Protection of trial subjects
    The subject voluntarily signed the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved Informed Consent form, prior to the conduct of any study procedures, or, where applicable (i.e., countries other than Germany) for a given subject, the subject's legally authorized representative (LAR) signed the IEC/IRB approved Informed Consent form on behalf of the subject, prior to the conduct of any procedures. For Germany, where the subject's LAR is not permitted to sign the IEC/IRB approved Informed Consent form on behalf of the subject, evaluation by an independent psychiatrist was to be sought if the investigator who was evaluating the subject for inclusion in the study doubted the subject's cognitive ability to independently provide informed consent.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Jan 2018
    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
    United States: 100
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Italy: 27
    Worldwide total number of subjects
    142
    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)
    23
    From 65 to 84 years
    117
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    All enrolled participants

    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
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Investigators and subjects remained blinded to the treatment assignments from the parent Study M15-562 and all parties were blinded to the dose level of tilavonemab in this study, M15-563. The M15-563 study was not placebo-controlled.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg
    Arm description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-8E12
    Investigational medicinal product code
    Other name
    Tilavonemab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.

    Investigational medicinal product name
    Placebo solution for IV infusion on Day 15
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.

    Arm title
    M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg
    Arm description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-8E12
    Investigational medicinal product code
    Other name
    Tilavonemab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.

    Investigational medicinal product name
    Placebo solution for IV infusion on Day 15
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.

    Arm title
    M15-562 Placebo/M15-563 ABBV-8E12 2000 mg
    Arm description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-8E12
    Investigational medicinal product code
    Other name
    Tilavonemab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.

    Arm title
    M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Arm description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
    Arm type
    Experimental

    Investigational medicinal product name
    ABBV-8E12
    Investigational medicinal product code
    Other name
    Tilavonemab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.

    Number of subjects in period 1
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Started
    51
    45
    23
    23
    Completed
    0
    0
    0
    0
    Not completed
    51
    45
    23
    23
         Adverse event, non-fatal
    2
    -
    -
    2
         Other, not specified
    44
    38
    21
    16
         Withdrew consent
    5
    7
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg
    Reporting group description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

    Reporting group title
    M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg
    Reporting group description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

    Reporting group title
    M15-562 Placebo/M15-563 ABBV-8E12 2000 mg
    Reporting group description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

    Reporting group title
    M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Reporting group description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

    Reporting group values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg Total
    Number of subjects
    51 45 23 23 142
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70.0 ( 6.05 ) 70.9 ( 6.58 ) 68.8 ( 5.81 ) 68.8 ( 5.78 ) -
    Gender categorical
    Units: Subjects
        Female
    14 22 12 8 56
        Male
    37 23 11 15 86

    End points

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    End points reporting groups
    Reporting group title
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg
    Reporting group description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

    Reporting group title
    M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg
    Reporting group description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

    Reporting group title
    M15-562 Placebo/M15-563 ABBV-8E12 2000 mg
    Reporting group description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

    Reporting group title
    M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Reporting group description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

    Primary: Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52

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    End point title
    Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 [1]
    End point description
    The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive values indicate worsening from baseline.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    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: Statistical analysis was not completed due to the early termination of the study.
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    9 [2]
    6 [3]
    7 [4]
    6 [5]
    Units: units on a scale
        arithmetic mean (standard deviation)
    14.4 ( 7.73 )
    2.3 ( 11.99 )
    13.1 ( 6.87 )
    4.2 ( 6.40 )
    Notes
    [2] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [3] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [4] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [5] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

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    End point title
    Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
    End point description
    The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive values indicate worsening from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    9 [6]
    6 [7]
    7 [8]
    6 [9]
    Units: units on a scale
        arithmetic mean (standard deviation)
    6.9 ( 4.37 )
    3.2 ( 5.27 )
    5.6 ( 5.68 )
    7.3 ( 6.28 )
    Notes
    [6] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [7] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [8] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [9] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52

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    End point title
    Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52
    End point description
    The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    50 [10]
    42 [11]
    22 [12]
    23 [13]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline of M15-563; n=50,42,22,23
    5.0 ( 0.89 )
    4.8 ( 0.92 )
    4.9 ( 0.92 )
    5.0 ( 0.91 )
        Week 52 of M15-563, n= 8,6,7,5
    5.1 ( 0.64 )
    5.2 ( 0.98 )
    5.9 ( 0.90 )
    5.4 ( 1.14 )
    Notes
    [10] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [11] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [12] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [13] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)

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    End point title
    Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
    End point description
    The Schwab and England Activities of Daily Living (SEADL) scale consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative values indicate worsening from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    9 [14]
    6 [15]
    7 [16]
    5 [17]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -13.3 ( 14.14 )
    -13.3 ( 12.11 )
    -10.0 ( 14.14 )
    -18.0 ( 13.04 )
    Notes
    [14] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [15] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [16] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [17] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score

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    End point title
    Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score
    End point description
    The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive values indicate worsening from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    8 [18]
    6 [19]
    7 [20]
    5 [21]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.6 ( 0.52 )
    1.3 ( 0.82 )
    1.3 ( 0.49 )
    0.6 ( 1.82 )
    Notes
    [18] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [19] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [20] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [21] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52

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    End point title
    Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52
    End point description
    The PGI-C is a participant’s rating of the change in their PSP-related symptoms since initiation of study drug. Participants rated their change in status using the following 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    48 [22]
    43 [23]
    23 [24]
    23 [25]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline of M15-563; n=48,43,23,23
    5.0 ( 1.03 )
    5.1 ( 1.04 )
    5.2 ( 1.30 )
    5.3 ( 1.15 )
        Week 52 of M15-563, n=9,6,7,6
    4.9 ( 1.62 )
    4.7 ( 1.51 )
    5.4 ( 0.53 )
    5.3 ( 1.37 )
    Notes
    [22] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [23] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [24] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [25] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score

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    End point title
    Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score
    End point description
    The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive values indicate worsening from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    9 [26]
    6 [27]
    7 [28]
    6 [29]
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.4 ( 1.74 )
    -0.2 ( 2.23 )
    2.0 ( 2.83 )
    1.0 ( 2.10 )
    Notes
    [26] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [27] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [28] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    [29] - ITT:subjects who rcvd any dose of study drug in this study w/ available data at baseline and Week 52
    No statistical analyses for this end point

    Secondary: Mean Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26

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    End point title
    Mean Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26
    End point description
    The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Number of subjects analysed
    51 [30]
    45 [31]
    23 [32]
    23 [33]
    Units: days
        median (confidence interval 95%)
    84.0 (29.0 to 86.0)
    85.0 (84.0 to 91.0)
    85.0 (42.0 to 91.0)
    84.0 (64.0 to 86.0)
    Notes
    [30] - ITT dataset: subjects who rcvd any dose of study drug in Study M15-563 and those with available data
    [31] - ITT dataset: subjects who rcvd any dose of study drug in Study M15-563 and those with available data
    [32] - ITT dataset: subjects who rcvd any dose of study drug in Study M15-563 and those with available data
    [33] - ITT dataset: subjects who rcvd any dose of study drug in Study M15-563 and those with available data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events and serious adverse events collected from 1st dose of study drug until 20 wks after discontinuation, up to 98 wks. Serious adverse events and protocol-related nonserious adverse events collected from informed consent.
    Adverse event reporting additional description
    TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks (approximately 5 half-lives) have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg
    Reporting group description
    Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

    Reporting group title
    M15-562 Placebo/M15-563 ABBV-8E12 2000 mg
    Reporting group description
    ntravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

    Reporting group title
    M15-562 ABBV-8E12 4000 mg / M15-563 ABBV-8E12 4000 mg
    Reporting group description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

    Reporting group title
    M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Reporting group description
    Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

    Serious adverse events
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg / M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 51 (19.61%)
    3 / 23 (13.04%)
    10 / 45 (22.22%)
    7 / 23 (30.43%)
         number of deaths (all causes)
    5
    1
    5
    2
         number of deaths resulting from adverse events
    4
    1
    3
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    COLORECTAL CANCER
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    LYMPHOMA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    CERVICAL VERTEBRAL FRACTURE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CLAVICLE FRACTURE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 23 (0.00%)
    2 / 45 (4.44%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    CARDIAC ARREST
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    LETHARGY
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 23 (4.35%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PARTIAL SEIZURES
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROGRESSIVE SUPRANUCLEAR PALSY
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 23 (4.35%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COMPLICATION ASSOCIATED WITH DEVICE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEATH
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    APNOEA
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    ASPIRATION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    3 / 45 (6.67%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    MENTAL STATUS CHANGES
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 23 (4.35%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    INFLUENZA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    KLEBSIELLA INFECTION
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    POST PROCEDURAL SEPSIS
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    M15-562 ABBV-8E12 2000 mg/ M15-563 ABBV-8E12 2000 mg M15-562 Placebo/M15-563 ABBV-8E12 2000 mg M15-562 ABBV-8E12 4000 mg / M15-563 ABBV-8E12 4000 mg M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 51 (35.29%)
    6 / 23 (26.09%)
    16 / 45 (35.56%)
    16 / 23 (69.57%)
    Investigations
    WEIGHT DECREASED
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 23 (4.35%)
    0 / 45 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    2
    2
    0
    3
    Injury, poisoning and procedural complications
    CHEST INJURY
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    0
    2
    CONTUSION
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 23 (4.35%)
    3 / 45 (6.67%)
    2 / 23 (8.70%)
         occurrences all number
    3
    2
    4
    5
    FALL
         subjects affected / exposed
    9 / 51 (17.65%)
    2 / 23 (8.70%)
    7 / 45 (15.56%)
    9 / 23 (39.13%)
         occurrences all number
    13
    8
    9
    20
    LIP INJURY
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 23 (4.35%)
    1 / 45 (2.22%)
    2 / 23 (8.70%)
         occurrences all number
    1
    1
    1
    2
    SKIN ABRASION
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 23 (8.70%)
    0 / 45 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    3
    2
    0
    3
    SKIN LACERATION
         subjects affected / exposed
    5 / 51 (9.80%)
    1 / 23 (4.35%)
    3 / 45 (6.67%)
    6 / 23 (26.09%)
         occurrences all number
    5
    4
    3
    9
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 23 (8.70%)
    0 / 45 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    2
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    1
    0
    0
    2
    PYREXIA
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    0 / 45 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    1
    0
    0
    3
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 23 (0.00%)
    2 / 45 (4.44%)
    2 / 23 (8.70%)
         occurrences all number
    4
    0
    2
    2
    DYSPHAGIA
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    3 / 23 (13.04%)
         occurrences all number
    2
    0
    1
    3
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 23 (8.70%)
    4 / 45 (8.89%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    4
    1
    Musculoskeletal and connective tissue disorders
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 23 (0.00%)
    1 / 45 (2.22%)
    3 / 23 (13.04%)
         occurrences all number
    1
    0
    1
    3
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 23 (8.70%)
    1 / 45 (2.22%)
    0 / 23 (0.00%)
         occurrences all number
    2
    2
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    7 / 51 (13.73%)
    1 / 23 (4.35%)
    7 / 45 (15.56%)
    2 / 23 (8.70%)
         occurrences all number
    11
    1
    10
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Mar 2018
    Amendment 1 ● Updated Overall Study Design and Plan: Description to reflect the anticipated number of participating sites due to an increase in the number of subjects, i.e., increasing from 180 to 330 ● Updated Inclusion Criteria and Section 9.3, Subject Information and Consent, to address informed consent procedures specific to Germany ● Updated Treatments Administered Section, to reflect the infusion rate in lieu of a length of infusion in minutes/hours ● Updated Identity of Investigational Product, to include a 1000 mg/10 mL formulation, in addition to the 300 mg/15 mL vial ● Update Preparation/Reconstitution of Dosage Form, Section 5.5.5, Blinding, and Section 5.5.7, Drug Accountability, to provide additional guidance on investigational product blinding and accountability.
    21 Feb 2019
    Amendment 2 ● Updated Inclusion Criteria to remove the need for subjects to sign an assent form ● Updated 12-Lead Electrocardiogram section, to remove the requirement for postdose ECG on Day 1 ● Updated Magnetic Resonance Imaging section to remove the requirement that study entry MRI must be completed after other relevant procedures have been completed ● Updated Magnetic Resonance Imaging section to add that if a subject cannot undergo MRI for clinical reasons, the AbbVie TA MD should be consulted for approval ● Updated Lumbar Puncture section to add that subjects who are unable to undergo an LP may be enrolled with permission of the AbbVie TA MD without the requirement of an LP during the study ● Updated Diagnostic Tools and Rating Scales to add a Treatment Satisfaction Questionnaire for Medication, PSP Caregiver Questionnaires, and the BioStamp nPoint device ● Updated Treatments Administered section to align the infusion rates in this extension study with those of the parent study (Study M15-562) ● Updated Storage and Disposition of Study Drug section, to clarify the requirements for reporting temperature excursions ● Updated Reporting section to correct the time frame for which product complaints must be reported ● Updated Overall Study Design and Plan: Description, to add a digital BioStamp substudy

    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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