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An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

Primary Purpose

Progressive Supranuclear Palsy (PSP)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-8E12
Placebo solution for IV infusion on Day 15
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)
  • In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)
  • Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Exclusion Criteria:

  • Participants who weigh less than 44 kg (97 lbs) at the time of study entry
  • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
  • Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
  • More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879)
  • Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations

Sites / Locations

  • Univ Alabama-Birmingham /ID# 165522
  • Mayo Clinic Arizona /ID# 165521
  • Cedars-Sinai Medical Center /ID# 165567
  • Usc /Id# 165529
  • University of California, Los Angeles /ID# 165669
  • University of California, San /ID# 165560
  • Univ California, San Francisco /ID# 165553
  • Rocky Mountain Movement Disorders Center /ID# 165559
  • UF Center for Movement Disorde /ID# 165561
  • Mayo Clinic /ID# 165554
  • University of South Florida /ID# 165556
  • Augusta University Medical Center /ID# 165562
  • Rush University Medical Center /ID# 165527
  • University of Chicago Medical /ID# 165555
  • Indiana University /ID# 165519
  • University of Kentucky Chandler Medical Center /ID# 165566
  • Mayo Clinic - Rochester /ID# 165518
  • Cleveland Clinic Lou Ruvo Cent /ID# 165538
  • Rutgers Robert Wood Johnson /ID# 165526
  • Columbia Univ Medical Center /ID# 165528
  • Cleveland Clinic Main Campus /ID# 165537
  • Vanderbilt Univ Med Ctr /ID# 165520
  • Kerwin Research Center /ID# 206872
  • McGovern Medical School /ID# 165565
  • Q-Pharm Pty Limited /ID# 165452
  • Royal Adelaide Hospital /ID# 165451
  • Alfred Hospital /ID# 165454
  • University of Calgary /ID# 165667
  • Toronto Western Hospital /ID# 165462
  • Montreal Neurological Institut /ID# 165546
  • CHUM - Notre-Dame Hospital /ID# 165461
  • Policlinico Agostino Gemelli /ID# 165536
  • University of Catanzaro /ID# 170214
  • Istituto Neuro Mediterraneo IR /ID# 165533
  • A.O. Santa Maria /ID# 165535
  • IRCCS San Camillo /ID# 201229
  • National Hospital Organization Higashinagoya National Hospital /ID# 208786
  • National Hospital Organization Asahikawa Medical Center /ID# 208818
  • National Hospital Organization Utano National Hospital /ID# 208780
  • NHO Sendai Nishitaga National Hospital /ID# 209014
  • Osaka University Hospital /ID# 208787
  • National Center of Neurology and Psychiatry /ID# 208820

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg

M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg

M15-562 Placebo/M15-563 ABBV-8E12 2000 mg

M15-562 Placebo/M15-563 ABBV-8E12 4000 mg

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52
The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive values indicate worsening from baseline.

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 values indicate worsening from baseline.
Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to 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 Schwab and England Activities of Daily Living Scale (SEADL)
The Schwab and England Activities of Daily Living (SEADL) scale consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative values indicate worsening from baseline.
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 values indicate worsening from baseline.
Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52
The PGI-C is a participant's rating of the change in their PSP-related symptoms since initiation of study drug. Participants rated their change in status using the following 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
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 values indicate worsening from baseline.
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 four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).

Full Information

First Posted
January 2, 2018
Last Updated
February 1, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03391765
Brief Title
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Official Title
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
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.
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
December 13, 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
Studies a U.S. FDA-regulated Device Product
No
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 the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).
Detailed Description
This study (M15-563) was a Phase 2, randomized, double-blind, multiple-dose, multicenter, long-term extension of NCT 02985879 (Study M15-562) in participants with progressive supranuclear palsy (PSP). Those who completed the 52-week Treatment Period in Study M15-562 and met all entry criteria were eligible for enrollment into this study. This study planned for a Treatment Period of up to 5 years and a post-treatment follow-up visit approximately 20 weeks after the last dose of study drug (including participants who prematurely discontinued treatment). All participants received ABBV-8E12 as follows: those who received placebo in Study M15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received ABBV-8E12 at a dose of either 2000 or 4000 mg in Study M15-562 continued on the same dose in this study. This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg
Arm Type
Experimental
Arm Description
Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
Arm Title
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg
Arm Type
Experimental
Arm Description
Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
Arm Title
M15-562 Placebo/M15-563 ABBV-8E12 2000 mg
Arm Type
Experimental
Arm Description
Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
Arm Title
M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
Arm Type
Experimental
Arm Description
Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
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.
Intervention Type
Drug
Intervention Name(s)
Placebo solution for IV infusion on Day 15
Intervention Description
0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
Primary Outcome Measure Information:
Title
Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52
Description
The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive values indicate worsening from baseline.
Time Frame
Baseline, Week 52
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 values indicate worsening from baseline.
Time Frame
Baseline, Week 52
Title
Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to 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
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) scale consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative values indicate worsening from baseline.
Time Frame
Baseline, Week 52
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 values indicate worsening from baseline.
Time Frame
Baseline, Week 52
Title
Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52
Description
The PGI-C is a participant's rating of the change in their PSP-related symptoms since initiation of study drug. Participants rated their change in status using the following 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
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 values indicate worsening from baseline.
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 four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).
Time Frame
From Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant completed the 52-week treatment period in Study M15-562 (NCT02985879) In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879) Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) Exclusion Criteria: Participants who weigh less than 44 kg (97 lbs) at the time of study entry Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI) Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879) Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Univ Alabama-Birmingham /ID# 165522
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Arizona /ID# 165521
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Cedars-Sinai Medical Center /ID# 165567
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Usc /Id# 165529
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles /ID# 165669
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San /ID# 165560
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Univ California, San Francisco /ID# 165553
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-2204
Country
United States
Facility Name
Rocky Mountain Movement Disorders Center /ID# 165559
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113-2736
Country
United States
Facility Name
UF Center for Movement Disorde /ID# 165561
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Mayo Clinic /ID# 165554
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida /ID# 165556
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Augusta University Medical Center /ID# 165562
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-0004
Country
United States
Facility Name
Rush University Medical Center /ID# 165527
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical /ID# 165555
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University /ID# 165519
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 165566
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 165518
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Cent /ID# 165538
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Rutgers Robert Wood Johnson /ID# 165526
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 165528
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 165537
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Vanderbilt Univ Med Ctr /ID# 165520
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Kerwin Research Center /ID# 206872
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4316
Country
United States
Facility Name
McGovern Medical School /ID# 165565
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Q-Pharm Pty Limited /ID# 165452
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 165451
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Hospital /ID# 165454
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
University of Calgary /ID# 165667
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Toronto Western Hospital /ID# 165462
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Montreal Neurological Institut /ID# 165546
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
CHUM - Notre-Dame Hospital /ID# 165461
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Policlinico Agostino Gemelli /ID# 165536
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
University of Catanzaro /ID# 170214
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Istituto Neuro Mediterraneo IR /ID# 165533
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
A.O. Santa Maria /ID# 165535
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
IRCCS San Camillo /ID# 201229
City
Venice
ZIP/Postal Code
30126
Country
Italy
Facility Name
National Hospital Organization Higashinagoya National Hospital /ID# 208786
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4658620
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 208818
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Utano National Hospital /ID# 208780
City
Kyoto City
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
NHO Sendai Nishitaga National Hospital /ID# 209014
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
982-8555
Country
Japan
Facility Name
Osaka University Hospital /ID# 208787
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Center of Neurology and Psychiatry /ID# 208820
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan

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

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An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

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