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A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

Primary Purpose

Progressive Supranuclear Palsy

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
ABBV-8E12
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring PSP, Steele-Richardson-Olszewski syndrome, Tauopathy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male or female participant with age 40 years or greater at the time of signed consent
  • Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome)
  • Presence of PSP symptoms for less than 5 years
  • Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker)
  • Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Key Exclusion Criteria:

  • Participants who weigh less than 44 kg (97 lbs) at screening
  • Mini-Mental State Examination (MMSE) score less than 15 at screening
  • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
  • Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
  • Evidence of any clinically significant neurological disorder other than PSP
  • The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria
  • Participant has had a significant illness or infection requiring medical intervention in the past 30 days

Sites / Locations

  • University of Alabama at Birmingham - Main /ID# 144892
  • Mayo Clinic - Scottsdale /ID# 144893
  • Cedars-Sinai Medical Center /ID# 149775
  • Ucsd /Id# 144905
  • Usc /Id# 149773
  • University of California, Los Angeles /ID# 144896
  • Univ California, San Francisco /ID# 144897
  • Rocky Mountain Movement Disorders Center /ID# 153397
  • University of Florida - Archer /ID# 144906
  • Mayo Clinic /ID# 144911
  • University of South Florida /ID# 144912
  • Georgia Regents University /ID# 144908
  • Rush University Medical Center /ID# 144894
  • University of Chicago /ID# 148672
  • Indiana University /ID# 149036
  • University of Kentucky Chandler Medical Center /ID# 144891
  • Mayo Clinic - Rochester /ID# 144895
  • St. Luke's Hosp. of Kansas Cit /ID# 168629
  • Cleveland Clinic Lou Ruvo Cent /ID# 148919
  • Rutgers Robert Wood Johnson /ID# 144901
  • COLUMBIA University Medical Center /ID# 149037
  • Cleveland Clinic Main Campus /ID# 144885
  • Oregon Health and Science University /ID# 149774
  • Vanderbilt Univ Med Ctr /ID# 144898
  • Kerwin Research Center /ID# 144904
  • McGovern Medical School /ID# 149236
  • Central Texas Neurology Consul /ID# 167417
  • Westmead Hospital /ID# 154403
  • Q-Pharm Pty Limited /ID# 154410
  • Royal Adelaide Hospital /ID# 153157
  • Alfred Hospital /ID# 153158
  • Neurodegenerative Disorders Re /ID# 153770
  • University of Calgary /ID# 154393
  • OCT Research ULC /ID# 169688
  • Toronto Western Hospital /ID# 152818
  • Crchum /Id# 152819
  • Montreal Neurological Institut /ID# 156413
  • Hopital Universitaire Purpan /ID# 153152
  • Hopital de la Timone /ID# 153113
  • Chu de Bordeaux Hopital /Id# 153151
  • Hopital B Roger Salengro /ID# 153943
  • Hopital Pitie Salpetriere /ID# 153942
  • CHU Strasbourg Hautepierre Hos /ID# 206942
  • St. Josef-Hospital /ID# 201984
  • Universitaetsklinikum Leipzig /ID# 201761
  • Universitaetsklinikum Ulm /ID# 153155
  • KH Agatharied /ID# 154166
  • TU Uniklinik Munchen /ID# 153154
  • Universita di Catanzaro Magna Graecia /ID# 166322
  • Policlinico Agostino Gemelli /ID# 153104
  • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982
  • Istituto Neuro Mediterraneo IR /ID# 153106
  • A.O. Santa Maria /ID# 153102
  • IRCCS Ospedale San Camillo /ID# 153101
  • National Hospital Organization Higashinagoya National Hospital /ID# 201514
  • National Hospital Organization Asahikawa Medical Center /ID# 201585
  • National Hospital Organization Utano National Hospital /ID# 201979
  • Tohoku University Hospital /ID# 202307
  • NHO Sendai Nishitaga National Hospital /ID# 202132
  • Niigata University Medical & Dental Hospital /ID# 201680
  • Osaka University Hospital /ID# 201980
  • Juntendo University Hospital /ID# 200870
  • National Center of Neurology and Psychiatry /ID# 202037
  • Hospital General Universitario Gregorio Maranon /ID# 200876
  • Hosp Univ Virgen del Rocio /ID# 201039

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

ABBV-8E12 2000 mg

ABBV-8E12 4000 mg

Arm Description

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

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)

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)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
December 1, 2016
Last Updated
February 1, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02985879
Brief Title
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy
Keywords
PSP, Steele-Richardson-Olszewski syndrome, Tauopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
ABBV-8E12 2000 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
ABBV-8E12 4000 mg
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ABBV-8E12
Other Intervention Name(s)
Tilavonemab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score
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 changes in score indicate worsening from baseline.
Time Frame
Baseline, Week 52
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
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 changes in score indicate worsening from baseline.
Time Frame
Baseline, Week 52
Title
Clinical Global Impression of Change (CGI-C) Score at Week 52
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.
Time Frame
Week 52
Title
Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
Description
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.
Time Frame
Baseline, Week 52
Title
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12
Description
The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.
Time Frame
First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Title
Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12
Description
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.
Time Frame
First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Title
Area Under the Concentration Time Curve (AUC) for ABBV-8E12
Description
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.
Time Frame
First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Title
Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)
Description
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.
Time Frame
First day of the Fifth Dosing Interval, Day 85
Title
Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score
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 changes in score indicate worsening from baseline.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score
Description
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.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score
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 changes in score indicate worsening from baseline.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, Week 52
Title
Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26
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. 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).
Time Frame
From Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female participant with age 40 years or greater at the time of signed consent Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome) Presence of PSP symptoms for less than 5 years Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker) Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) Key Exclusion Criteria: Participants who weigh less than 44 kg (97 lbs) at screening Mini-Mental State Examination (MMSE) score less than 15 at screening Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI) Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period Evidence of any clinically significant neurological disorder other than PSP The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria Participant has had a significant illness or infection requiring medical intervention in the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 144892
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic - Scottsdale /ID# 144893
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Cedars-Sinai Medical Center /ID# 149775
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Ucsd /Id# 144905
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Usc /Id# 149773
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles /ID# 144896
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ California, San Francisco /ID# 144897
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-2204
Country
United States
Facility Name
Rocky Mountain Movement Disorders Center /ID# 153397
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113-2736
Country
United States
Facility Name
University of Florida - Archer /ID# 144906
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic /ID# 144911
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida /ID# 144912
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Regents University /ID# 144908
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush University Medical Center /ID# 144894
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago /ID# 148672
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Indiana University /ID# 149036
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 144891
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 144895
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
St. Luke's Hosp. of Kansas Cit /ID# 168629
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Cent /ID# 148919
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Rutgers Robert Wood Johnson /ID# 144901
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
COLUMBIA University Medical Center /ID# 149037
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 144885
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University /ID# 149774
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt Univ Med Ctr /ID# 144898
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Kerwin Research Center /ID# 144904
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4316
Country
United States
Facility Name
McGovern Medical School /ID# 149236
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Central Texas Neurology Consul /ID# 167417
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Westmead Hospital /ID# 154403
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Q-Pharm Pty Limited /ID# 154410
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 153157
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Hospital /ID# 153158
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Neurodegenerative Disorders Re /ID# 153770
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
University of Calgary /ID# 154393
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
OCT Research ULC /ID# 169688
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Toronto Western Hospital /ID# 152818
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Crchum /Id# 152819
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal Neurological Institut /ID# 156413
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Hopital Universitaire Purpan /ID# 153152
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital de la Timone /ID# 153113
City
Marseille CEDEX 05
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
13385
Country
France
Facility Name
Chu de Bordeaux Hopital /Id# 153151
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital B Roger Salengro /ID# 153943
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Pitie Salpetriere /ID# 153942
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Strasbourg Hautepierre Hos /ID# 206942
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
St. Josef-Hospital /ID# 201984
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitaetsklinikum Leipzig /ID# 201761
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 153155
City
Ulm
State/Province
Thueringen
ZIP/Postal Code
89081
Country
Germany
Facility Name
KH Agatharied /ID# 154166
City
Hausham
ZIP/Postal Code
83734
Country
Germany
Facility Name
TU Uniklinik Munchen /ID# 153154
City
Munich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Universita di Catanzaro Magna Graecia /ID# 166322
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Policlinico Agostino Gemelli /ID# 153104
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Neuro Mediterraneo IR /ID# 153106
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
A.O. Santa Maria /ID# 153102
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
IRCCS Ospedale San Camillo /ID# 153101
City
Venezia LIDO
ZIP/Postal Code
30126
Country
Italy
Facility Name
National Hospital Organization Higashinagoya National Hospital /ID# 201514
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4658620
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 201585
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Utano National Hospital /ID# 201979
City
Kyoto City
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Tohoku University Hospital /ID# 202307
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
NHO Sendai Nishitaga National Hospital /ID# 202132
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
982-8555
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital /ID# 201680
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka University Hospital /ID# 201980
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Juntendo University Hospital /ID# 200870
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
National Center of Neurology and Psychiatry /ID# 202037
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 200876
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp Univ Virgen del Rocio /ID# 201039
City
Sevilla
ZIP/Postal Code
41001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
33609476
Citation
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.
Results Reference
derived

Learn more about this trial

A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

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