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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001635-12 | EudraCT Number |
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This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.
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The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind treatment period, and a post-treatment follow-up period of approximately 20 weeks following last study drug administration (for those participants who prematurely discontinued from treatment, declined to participate in or did not qualify for participation in a long term extension [LTE] study). At the end of the treatment period, extended treatment was available for eligible participants who completed the 52-week treatment period and entered the separate long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK) assessments in the first 30 participants enrolled into the global study from countries other than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in the global study not participating in Cohort 1 or Cohort J1.
This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks |
|
| ABBV-8E12 2000 mg | Experimental | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
|
| ABBV-8E12 4000 mg | Experimental | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score | 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 changes in score indicate worsening from baseline. | Baseline, Week 52 |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section. | From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | 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 changes in score indicate worsening from baseline. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 144892 | Birmingham | Alabama | 35233 | United States | ||
| Mayo Clinic - Scottsdale /ID# 144893 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33609476 | Derived | Hoglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021 Mar;20(3):182-192. doi: 10.1016/S1474-4422(20)30489-0. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
All randomized participants; one participant in the ABBV-8E12 2000 mg dose group never received study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks |
| FG001 | ABBV-8E12 2000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2018 | Nov 2, 2020 |
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| ABBV-8E12 | Drug | 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. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data. |
|
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| Baseline, Week 52 |
| Clinical Global Impression of Change (CGI-C) Score at Week 52 | 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. | Week 52 |
| Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) | The Schwab and England Activities of Daily Living (SEADL) 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 changes in values indicate a decline in health. | Baseline, Week 52 |
| Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 | The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined. | First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113 |
| Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12 | The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1. | First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113 |
| Area Under the Concentration Time Curve (AUC) for ABBV-8E12 | The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1. | First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113 |
| Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough) | The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1. | First day of the Fifth Dosing Interval, Day 85 |
| Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score | 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 changes in score indicate worsening from baseline. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score | The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score | 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 changes in score indicate worsening from baseline. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume. | Baseline, Week 52 |
| Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume. | Baseline, Week 52 |
| Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26 | 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. 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). | From Baseline to Week 52 |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Cedars-Sinai Medical Center /ID# 149775 | Beverly Hills | California | 90211 | United States |
| Ucsd /Id# 144905 | La Jolla | California | 92093 | United States |
| Usc /Id# 149773 | Los Angeles | California | 90033 | United States |
| University of California, Los Angeles /ID# 144896 | Los Angeles | California | 90095 | United States |
| Univ California, San Francisco /ID# 144897 | San Francisco | California | 94143-2204 | United States |
| Rocky Mountain Movement Disorders Center /ID# 153397 | Englewood | Colorado | 80113-2736 | United States |
| University of Florida - Archer /ID# 144906 | Gainesville | Florida | 32610 | United States |
| Mayo Clinic /ID# 144911 | Jacksonville | Florida | 32224 | United States |
| University of South Florida /ID# 144912 | Tampa | Florida | 33612 | United States |
| Georgia Regents University /ID# 144908 | Augusta | Georgia | 30912 | United States |
| Rush University Medical Center /ID# 144894 | Chicago | Illinois | 60612 | United States |
| University of Chicago /ID# 148672 | Chicago | Illinois | 60637-1443 | United States |
| Indiana University /ID# 149036 | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Chandler Medical Center /ID# 144891 | Lexington | Kentucky | 40536 | United States |
| Mayo Clinic - Rochester /ID# 144895 | Rochester | Minnesota | 55905-0001 | United States |
| St. Luke's Hosp. of Kansas Cit /ID# 168629 | Kansas City | Missouri | 64111 | United States |
| Cleveland Clinic Lou Ruvo Cent /ID# 148919 | Las Vegas | Nevada | 89106 | United States |
| Rutgers Robert Wood Johnson /ID# 144901 | New Brunswick | New Jersey | 08901 | United States |
| COLUMBIA University Medical Center /ID# 149037 | New York | New York | 10032-3725 | United States |
| Cleveland Clinic Main Campus /ID# 144885 | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University /ID# 149774 | Portland | Oregon | 97239 | United States |
| Vanderbilt Univ Med Ctr /ID# 144898 | Nashville | Tennessee | 37232-0011 | United States |
| Kerwin Research Center /ID# 144904 | Dallas | Texas | 75231-4316 | United States |
| McGovern Medical School /ID# 149236 | Houston | Texas | 77054 | United States |
| Central Texas Neurology Consul /ID# 167417 | Round Rock | Texas | 78681 | United States |
| Westmead Hospital /ID# 154403 | Westmead | New South Wales | 2145 | Australia |
| Q-Pharm Pty Limited /ID# 154410 | Herston | Queensland | 4006 | Australia |
| Royal Adelaide Hospital /ID# 153157 | Adelaide | South Australia | 5000 | Australia |
| Alfred Hospital /ID# 153158 | Melbourne | Victoria | 3004 | Australia |
| Neurodegenerative Disorders Re /ID# 153770 | West Perth | Western Australia | 6005 | Australia |
| University of Calgary /ID# 154393 | Calgary | Alberta | T2N 4Z6 | Canada |
| OCT Research ULC /ID# 169688 | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Toronto Western Hospital /ID# 152818 | Toronto | Ontario | M5T 2S8 | Canada |
| Crchum /Id# 152819 | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Institut /ID# 156413 | Montreal | Quebec | H3A 2B4 | Canada |
| Hopital Universitaire Purpan /ID# 153152 | Toulouse | Haute-Garonne | 31059 | France |
| Hopital de la Timone /ID# 153113 | Marseille | Provence-Alpes-Côte d'Azur Region | 13385 | France |
| Chu de Bordeaux Hopital /Id# 153151 | Bordeaux | 33076 | France |
| Hopital B Roger Salengro /ID# 153943 | Lille | 59037 | France |
| Hopital Pitie Salpetriere /ID# 153942 | Paris | 75651 | France |
| CHU Strasbourg Hautepierre Hos /ID# 206942 | Strasbourg | 67200 | France |
| St. Josef-Hospital /ID# 201984 | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universitaetsklinikum Leipzig /ID# 201761 | Leipzig | Saxony | 04103 | Germany |
| Universitaetsklinikum Ulm /ID# 153155 | Ulm | Thuringia | 89081 | Germany |
| KH Agatharied /ID# 154166 | Hausham | 83734 | Germany |
| TU Uniklinik Munchen /ID# 153154 | Munich | 80802 | Germany |
| Universita di Catanzaro Magna Graecia /ID# 166322 | Catanzaro | Calabria | 88100 | Italy |
| Policlinico Agostino Gemelli /ID# 153104 | Rome | Lazio | 00168 | Italy |
| IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092 | Rozzano | Milano | 20089 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982 | Milan | 20133 | Italy |
| Istituto Neuro Mediterraneo IR /ID# 153106 | Pozzilli | 86077 | Italy |
| A.O. Santa Maria /ID# 153102 | Terni | 05100 | Italy |
| IRCCS Ospedale San Camillo /ID# 153101 | Venezia LIDO | 30126 | Italy |
| National Hospital Organization Higashinagoya National Hospital /ID# 201514 | Nagoya | Aichi-ken | 4658620 | Japan |
| National Hospital Organization Asahikawa Medical Center /ID# 201585 | Asahikawa | Hokkaido | 070-8644 | Japan |
| National Hospital Organization Utano National Hospital /ID# 201979 | Kyoto | Kyoto | 616-8255 | Japan |
| Tohoku University Hospital /ID# 202307 | Sendai | Miyagi | 980-8574 | Japan |
| NHO Sendai Nishitaga National Hospital /ID# 202132 | Sendai | Miyagi | 982-8555 | Japan |
| Niigata University Medical & Dental Hospital /ID# 201680 | Niigata | Niigata | 951-8520 | Japan |
| Osaka University Hospital /ID# 201980 | Suita-shi | Osaka | 565-0871 | Japan |
| Juntendo University Hospital /ID# 200870 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| National Center of Neurology and Psychiatry /ID# 202037 | Kodaira | Tokyo | 187-8551 | Japan |
| Hospital General Universitario Gregorio Maranon /ID# 200876 | Madrid | 28007 | Spain |
| Hosp Univ Virgen del Rocio /ID# 201039 | Seville | 41001 | Spain |
| FG002 | ABBV-8E12 4000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
| COMPLETED |
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| NOT COMPLETED |
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Safety dataset: all randomized participants who received at least one dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks |
| BG001 | ABBV-8E12 2000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
| BG002 | ABBV-8E12 4000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score | 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 changes in score indicate worsening from baseline. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 52 |
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| Primary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section. | Safety Dataset: all randomized participants who received at least one dose of study drug | Posted | Count of Participants | Participants | No | From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks |
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| Secondary | Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) | 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 changes in score indicate worsening from baseline. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 52 |
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| Secondary | Clinical Global Impression of Change (CGI-C) Score at Week 52 | 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. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at Week 52 | Posted | Least Squares Mean | Standard Error | units on a scale | Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | mm^3 | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) | The Schwab and England Activities of Daily Living (SEADL) 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 changes in values indicate a decline in health. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | percentage of independence | Baseline, Week 52 |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 | The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined. | Participants in Cohort 1 and Cohort J1 with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113 |
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| Secondary | Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12 | The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1. | Participants in Cohort 1 and Cohort J1 with available data | Posted | Median | Full Range | hours | First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113 |
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| Secondary | Area Under the Concentration Time Curve (AUC) for ABBV-8E12 | The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1. | Participants in Cohort 1 and Cohort J1 with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | µg•day/mL | First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113 |
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| Secondary | Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough) | The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1. | Participants in Cohort 1 and Cohort J1 with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | First day of the Fifth Dosing Interval, Day 85 |
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| Secondary | Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score | 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 changes in score indicate worsening from baseline. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score | The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score | 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 changes in score indicate worsening from baseline. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | mm^3 | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | mm^3 | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | mm^3 | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | mm^3 | Baseline, Week 52 |
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| Secondary | Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume. | ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52 | Posted | Least Squares Mean | Standard Error | mm^3 | Baseline, Week 52 |
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| Secondary | Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26 | 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. 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). | ITT dataset: all randomized participants who received at least one dose of study drug with available data | Posted | Median | 95% Confidence Interval | days | From Baseline to Week 52 |
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and TESAEs are defined as any AE or TESAE 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks | 8 | 126 | 33 | 126 | 83 | 126 |
| EG001 | ABBV-8E12 2000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) | 9 | 126 | 29 | 126 | 75 | 126 |
| EG002 | ABBV-8E12 4000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) | 9 | 125 | 34 | 125 | 80 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EYE SWELLING | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ENTEROVESICAL FISTULA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HYPERMOTILITY | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLECYSTITIS INFECTIVE | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ORCHITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA MYCOPLASMAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| BRAIN CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FOREIGN BODY ASPIRATION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| GUN SHOT WOUND | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKULL FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RESIDUAL URINE VOLUME | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MUSCLE RIGIDITY | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| PROSTATE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BRAIN MIDLINE SHIFT | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PROGRESSIVE SUPRANUCLEAR PALSY | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SPINAL STROKE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUBDURAL HYGROMA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BLADDER OBSTRUCTION | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MICTURITION DISORDER | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOKING | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2018 | Nov 2, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| D024801 | Tauopathies |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628586 | tilavonemab |
Not provided
Not provided
Not provided
| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or other Pacific Islander |
|
| Multiple |
|
| ABBV-8E12 4000 mg vs Placebo | Mixed-effects model, repeated measures | =0.464 | LS Mean Difference | 1.0 | Standard Error of the Mean | 1.32 | 2-Sided | 95 | -1.63 | 3.58 | ABBV-8E12 4000 mg - Placebo | Superiority | The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score. |
Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
| OG002 | ABBV-8E12 4000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
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| OG002 | ABBV-8E12 4000mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
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First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg |
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| Cohort J1, ABBV-8E12 4000 mg |
First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg |
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| OG003 | Cohort J1, ABBV-8E12 4000 mg | First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg |
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| Cohort J1, ABBV-8E12 4000 mg |
First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg |
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Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
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Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
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| OG002 | ABBV-8E12 4000 mg | Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain) |
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