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

• Sponsor: AbbVie (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03391765
• Collaborator: (none)
• Enrollment: 142
• Locations: 42
• Arms: 4
• Actual Duration (Months): 22.6
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Progressive Supranuclear Palsy (PSP)	Drug: ABBV-8E12; Drug: Placebo solution for IV infusion on Day 15	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
• Actual Study Start Date: Jan 24, 2018
• Actual Primary Completion Date: Dec 13, 2019
• Actual Study Completion Date: Dec 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg 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).	Drug: ABBV-8E12; 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.; Other Names: Tilavonemab ; Drug: Placebo solution for IV infusion on Day 15; 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.
Experimental: M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg 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).	Drug: ABBV-8E12; 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.; Other Names: Tilavonemab ; Drug: Placebo solution for IV infusion on Day 15; 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.
Experimental: M15-562 Placebo/M15-563 ABBV-8E12 2000 mg 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.	Drug: ABBV-8E12; 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.; Other Names: Tilavonemab
Experimental: M15-562 Placebo/M15-563 ABBV-8E12 4000 mg 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.	Drug: ABBV-8E12; 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.; Other Names: Tilavonemab

Outcome Measures

Primary Outcome Measures

1. Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 [Baseline, 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

1. Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [Baseline, Week 52]

   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.

2. Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52 [Baseline, 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.

3. Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) [Baseline, Week 52]

   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.

4. Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score [Baseline, Week 52]

   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.

5. Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52 [Baseline, 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.

6. Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score [Baseline, Week 52]

   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.

7. Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26 [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 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ Alabama-Birmingham /ID# 165522	Birmingham	Alabama	United States	35294
2	Mayo Clinic Arizona /ID# 165521	Phoenix	Arizona	United States	85054
3	Cedars-Sinai Medical Center /ID# 165567	Beverly Hills	California	United States	90211
4	Usc /Id# 165529	Los Angeles	California	United States	90033
5	University of California, Los Angeles /ID# 165669	Los Angeles	California	United States	90095
6	University of California, San /ID# 165560	San Diego	California	United States	92037
7	Univ California, San Francisco /ID# 165553	San Francisco	California	United States	94143-2204
8	Rocky Mountain Movement Disorders Center /ID# 165559	Englewood	Colorado	United States	80113-2736
9	UF Center for Movement Disorde /ID# 165561	Gainesville	Florida	United States	32607
10	Mayo Clinic /ID# 165554	Jacksonville	Florida	United States	32224
11	University of South Florida /ID# 165556	Tampa	Florida	United States	33612
12	Augusta University Medical Center /ID# 165562	Augusta	Georgia	United States	30912-0004
13	Rush University Medical Center /ID# 165527	Chicago	Illinois	United States	60612
14	University of Chicago Medical /ID# 165555	Chicago	Illinois	United States	60637
15	Indiana University /ID# 165519	Indianapolis	Indiana	United States	46202
16	University of Kentucky Chandler Medical Center /ID# 165566	Lexington	Kentucky	United States	40536
17	Mayo Clinic - Rochester /ID# 165518	Rochester	Minnesota	United States	55905-0001
18	Cleveland Clinic Lou Ruvo Cent /ID# 165538	Las Vegas	Nevada	United States	89106
19	Rutgers Robert Wood Johnson /ID# 165526	New Brunswick	New Jersey	United States	08901
20	Columbia Univ Medical Center /ID# 165528	New York	New York	United States	10032-3725
21	Cleveland Clinic Main Campus /ID# 165537	Cleveland	Ohio	United States	44195
22	Vanderbilt Univ Med Ctr /ID# 165520	Nashville	Tennessee	United States	37232-0011
23	Kerwin Research Center /ID# 206872	Dallas	Texas	United States	75231-4316
24	McGovern Medical School /ID# 165565	Houston	Texas	United States	77054
25	Q-Pharm Pty Limited /ID# 165452	Herston	Queensland	Australia	4006
26	Royal Adelaide Hospital /ID# 165451	Adelaide	South Australia	Australia	5000
27	Alfred Hospital /ID# 165454	Melbourne	Victoria	Australia	3004
28	University of Calgary /ID# 165667	Calgary	Alberta	Canada	T2N 4Z6
29	Toronto Western Hospital /ID# 165462	Toronto	Ontario	Canada	M5T 2S8
30	Montreal Neurological Institut /ID# 165546	Montreal	Quebec	Canada	H3A 2B4
31	CHUM - Notre-Dame Hospital /ID# 165461	Montréal	Quebec	Canada	H2X 0A9
32	Policlinico Agostino Gemelli /ID# 165536	Rome	Lazio	Italy	00168
33	University of Catanzaro /ID# 170214	Catanzaro		Italy	88100
34	Istituto Neuro Mediterraneo IR /ID# 165533	Pozzilli		Italy	86077
35	A.O. Santa Maria /ID# 165535	Terni		Italy	05100
36	IRCCS San Camillo /ID# 201229	Venice		Italy	30126
37	National Hospital Organization Higashinagoya National Hospital /ID# 208786	Nagoya-shi	Aichi	Japan	4658620
38	National Hospital Organization Asahikawa Medical Center /ID# 208818	Asahikawa	Hokkaido	Japan	070-8644
39	National Hospital Organization Utano National Hospital /ID# 208780	Kyoto City	Kyoto	Japan	616-8255
40	NHO Sendai Nishitaga National Hospital /ID# 209014	Sendai	Miyagi	Japan	982-8555
41	Osaka University Hospital /ID# 208787	Suita-shi	Osaka	Japan	565-0871
42	National Center of Neurology and Psychiatry /ID# 208820	Kodaira	Tokyo	Japan	187-8551

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Study Protocol - Feb 21, 2019
• Statistical Analysis Plan - Aug 15, 2019

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03391765
• Other Study ID Numbers: M15-563; 2017-001590-16
• First Posted: Jan 5, 2018
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by AbbVie: Tauopathy; Steele-Richardson-Olszewski Syndrome; PSP
• Additional relevant MeSH terms: Supranuclear Palsy, Progressive; Tilavonemab

Study Results

Participant Flow

Pre-assignment Detail	All enrolled participants

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Period Title: Overall Study
STARTED	51	45	23	23
COMPLETED	0	0	0	0
NOT COMPLETED	51	45	23	23

Baseline Characteristics

Arm/Group Title	M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg	M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg	M15-562 Placebo/M15-563 ABBV-8E12 2000 mg	M15-562 Placebo/M15-563 ABBV-8E12 4000 mg	Total
Arm/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.	Total of all reporting groups
Overall Participants	51	45	23	23	142
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.0 (6.05)	70.9 (6.58)	68.8 (5.81)	68.8 (5.78)	69.9 (6.14)
Sex: Female, Male (Count of Participants)
Female	14 27.5%	22 48.9%	12 52.2%	8 34.8%	56 39.4%
Male	37 72.5%	23 51.1%	11 47.8%	15 65.2%	86 60.6%
Race/Ethnicity, Customized (Count of Participants)
White	47 92.2%	42 93.3%	22 95.7%	22 95.7%	133 93.7%
Black or African American	2 3.9%	1 2.2%	0 0%	0 0%	3 2.1%
Asian	1 2%	2 4.4%	1 4.3%	1 4.3%	5 3.5%
American Indian or Alaska Native	1 2%	0 0%	0 0%	0 0%	1 0.7%
Native Hawaiian or other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Multiple	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	9	6	7	6
Mean (Standard Deviation) [units on a scale]	14.4 (7.73)	2.3 (11.99)	13.1 (6.87)	4.2 (6.40)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	9	6	7	6
Mean (Standard Deviation) [units on a scale]	6.9 (4.37)	3.2 (5.27)	5.6 (5.68)	7.3 (6.28)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	50	42	22	23
Baseline of M15-563	5.0 (0.89)	4.8 (0.92)	4.9 (0.92)	5.0 (0.91)
Week 52 of M15-563	5.1 (0.64)	5.2 (0.98)	5.9 (0.90)	5.4 (1.14)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	9	6	7	5
Mean (Standard Deviation) [units on a scale]	-13.3 (14.14)	-13.3 (12.11)	-10.0 (14.14)	-18.0 (13.04)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	8	6	7	5
Mean (Standard Deviation) [units on a scale]	0.6 (0.52)	1.3 (0.82)	1.3 (0.49)	0.6 (1.82)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	48	43	23	23
Baseline of M15-563	5.0 (1.03)	5.1 (1.04)	5.2 (1.30)	5.3 (1.15)
Week 52 of M15-563	4.9 (1.62)	4.7 (1.51)	5.4 (0.53)	5.3 (1.37)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	9	6	7	6
Mean (Standard Deviation) [units on a scale]	2.4 (1.74)	-0.2 (2.23)	2.0 (2.83)	1.0 (2.10)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data

Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).	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.
Measure Participants	51	45	23	23
Median (95% Confidence Interval) [days]	84.0	85.0	85.0	84.0

Adverse Events

Time Frame	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 98 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.
Adverse Event Reporting Description	TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks (approximately 5 half-lives) have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	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/Group Description	Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).		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.
All Cause Mortality
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/51 (9.8%)		5/45 (11.1%)		1/23 (4.3%)		2/23 (8.7%)
Serious Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/51 (19.6%)		10/45 (22.2%)		3/23 (13%)		7/23 (30.4%)
Cardiac disorders
CARDIAC ARREST	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
CARDIO-RESPIRATORY ARREST	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
Gastrointestinal disorders
INTESTINAL OBSTRUCTION	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
General disorders
ASTHENIA	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
COMPLICATION ASSOCIATED WITH DEVICE	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
DEATH	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
Infections and infestations
INFLUENZA	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
KLEBSIELLA INFECTION	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
PNEUMONIA	3/51 (5.9%)	5	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
POST PROCEDURAL SEPSIS	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
SEPSIS	2/51 (3.9%)	2	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
UPPER RESPIRATORY TRACT INFECTION	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
URINARY TRACT INFECTION	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	1/23 (4.3%)	1
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
CLAVICLE FRACTURE	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
FALL	2/51 (3.9%)	2	2/45 (4.4%)	2	0/23 (0%)	0	1/23 (4.3%)	1
HIP FRACTURE	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
RIB FRACTURE	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL CANCER	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
LYMPHOMA	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
Nervous system disorders
LETHARGY	0/51 (0%)	0	0/45 (0%)	0	1/23 (4.3%)	1	0/23 (0%)	0
PARTIAL SEIZURES	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
PROGRESSIVE SUPRANUCLEAR PALSY	0/51 (0%)	0	1/45 (2.2%)	1	1/23 (4.3%)	1	0/23 (0%)	0
Psychiatric disorders
MENTAL STATUS CHANGES	0/51 (0%)	0	0/45 (0%)	0	1/23 (4.3%)	1	0/23 (0%)	0
Respiratory, thoracic and mediastinal disorders
APNOEA	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	0/23 (0%)	0
ASPIRATION	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1
DYSPNOEA	0/51 (0%)	0	1/45 (2.2%)	1	0/23 (0%)	0	0/23 (0%)	0
PNEUMONIA ASPIRATION	0/51 (0%)	0	3/45 (6.7%)	3	0/23 (0%)	0	0/23 (0%)	0
Other (Not Including Serious) Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/51 (35.3%)		16/45 (35.6%)		6/23 (26.1%)		16/23 (69.6%)
Gastrointestinal disorders
CONSTIPATION	4/51 (7.8%)	4	2/45 (4.4%)	2	0/23 (0%)	0	2/23 (8.7%)	2
DYSPHAGIA	2/51 (3.9%)	2	1/45 (2.2%)	1	0/23 (0%)	0	3/23 (13%)	3
General disorders
ASTHENIA	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	2/23 (8.7%)	2
PYREXIA	1/51 (2%)	1	0/45 (0%)	0	0/23 (0%)	0	3/23 (13%)	3
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	2/51 (3.9%)	2	1/45 (2.2%)	1	2/23 (8.7%)	2	0/23 (0%)	0
URINARY TRACT INFECTION	7/51 (13.7%)	11	7/45 (15.6%)	10	1/23 (4.3%)	1	2/23 (8.7%)	2
Injury, poisoning and procedural complications
CHEST INJURY	0/51 (0%)	0	0/45 (0%)	0	0/23 (0%)	0	2/23 (8.7%)	2
CONTUSION	2/51 (3.9%)	3	3/45 (6.7%)	4	1/23 (4.3%)	2	2/23 (8.7%)	5
FALL	9/51 (17.6%)	13	7/45 (15.6%)	9	2/23 (8.7%)	8	9/23 (39.1%)	20
LIP INJURY	1/51 (2%)	1	1/45 (2.2%)	1	1/23 (4.3%)	1	2/23 (8.7%)	2
SKIN ABRASION	3/51 (5.9%)	3	0/45 (0%)	0	2/23 (8.7%)	2	3/23 (13%)	3
SKIN LACERATION	5/51 (9.8%)	5	3/45 (6.7%)	3	1/23 (4.3%)	4	6/23 (26.1%)	9
Investigations
WEIGHT DECREASED	2/51 (3.9%)	2	0/45 (0%)	0	1/23 (4.3%)	2	3/23 (13%)	3
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY	1/51 (2%)	1	1/45 (2.2%)	1	0/23 (0%)	0	3/23 (13%)	3
Psychiatric disorders
ANXIETY	0/51 (0%)	0	4/45 (8.9%)	4	2/23 (8.7%)	2	1/23 (4.3%)	1
Vascular disorders
HYPOTENSION	1/51 (2%)	1	0/45 (0%)	0	2/23 (8.7%)	2	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.