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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391765
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy (PSP) Drug: ABBV-8E12 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 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 : January 24, 2018
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : November 20, 2019


Arm Intervention/treatment
Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab

Experimental: Group 1
Dose 1 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Name: Tilavonemab




Primary Outcome Measures :
  1. Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years [ Time Frame: Up to approximately 5 years ]
    The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).


Secondary Outcome Measures :
  1. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [ Time Frame: Up to approximately 5 years ]
    The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.

  2. Change in Clinical Global Impression of Change (CGI-C) [ Time Frame: Up to approximately 5 years ]
    The CGI-C is a clinician's rating of change in disease severity.

  3. Change in Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: Up to approximately 5 years ]
    The SEADL assesses the subject's ability to perform daily activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391765


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03391765    
Other Study ID Numbers: M15-563
2017-001590-16 ( EudraCT Number )
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
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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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:
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Supranuclear Palsy, Progressive
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases
ABBV-8E12
Nootropic Agents