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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03391765




Registration number
NCT03391765
Ethics application status
Date submitted
2/01/2018
Date registered
5/01/2018
Date last updated
5/08/2019

Titles & IDs
Public title
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Scientific title
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Secondary ID [1] 0 0
2017-001590-16
Secondary ID [2] 0 0
M15-563
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive Supranuclear Palsy (PSP) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-8E12

Experimental: Group 2 - Dose 2 ABBV-8E12

Experimental: Group 1 - Dose 1 ABBV-8E12


Treatment: Drugs: ABBV-8E12
ABBV-8E12 solution for IV infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years - The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) - The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Change in Clinical Global Impression of Change (CGI-C) - The CGI-C is a clinician's rating of change in disease severity.
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Change in Schwab and England Activities of Daily Living Scale (SEADL) - The SEADL assesses the subject's ability to perform daily activities.
Timepoint [3] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
- Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).

- In the opinion of the investigator, the subject was compliant during participation in
Study M15-562 (NCT02985879).

- Subject has an identified, reliable, study partner (e.g., caregiver, family member,
social worker, or friend).
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects 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).

- Subject 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 subject received his/her last dose of study
drug in Study M15-562 (NCT02985879).

- Subject is considered by the investigator, for any reason, to be an unsuitable
candidate to receive ABBV-8E12 or the subject is considered by the investigator to be
unable or unlikely to comply with the dosing schedule or study evaluations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 170218 - Westmead
Recruitment hospital [2] 0 0
Q-Pharm Pty Limited /ID# 165452 - Herston
Recruitment hospital [3] 0 0
Royal Adelaide Hospital /ID# 165451 - Adelaide
Recruitment hospital [4] 0 0
Alfred Hospital /ID# 165454 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
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United States of America
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Minnesota
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Haute-Garonne
Country [22] 0 0
France
State/province [22] 0 0
Provence-Alpes-Cote-d Azur
Country [23] 0 0
France
State/province [23] 0 0
Bordeaux
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France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
Italy
State/province [26] 0 0
Lazio
Country [27] 0 0
Italy
State/province [27] 0 0
Milano
Country [28] 0 0
Italy
State/province [28] 0 0
Catanzaro
Country [29] 0 0
Italy
State/province [29] 0 0
Milan
Country [30] 0 0
Italy
State/province [30] 0 0
Pozzilli
Country [31] 0 0
Italy
State/province [31] 0 0
Terni
Country [32] 0 0
Italy
State/province [32] 0 0
Venice
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi
Country [34] 0 0
Japan
State/province [34] 0 0
Hokkaido
Country [35] 0 0
Japan
State/province [35] 0 0
Kyoto
Country [36] 0 0
Japan
State/province [36] 0 0
Miyagi
Country [37] 0 0
Japan
State/province [37] 0 0
Niigata
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in
subjects with progressive supranuclear palsy (PSP). In a subset of participants at
participating sites, participants will be assigned digital sensor BioStamp to assess body
position and gait.
Trial website
https://clinicaltrials.gov/show/NCT03391765
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications