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A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With 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: NCT02985879
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE December 1, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE December 12, 2016
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
  • Change from Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score [ Time Frame: Baseline, Week 52 ]
    The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
  • Adverse Events [ Time Frame: 68 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Change in Progressive Supranuclear Palsy Rating Scale (PSP-RS) Total Score from Baseline to Week 52 [ Time Frame: 52 weeks ]
    The PSP-RS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
  • Adverse Events [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Change from Baseline to Week 52 in Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline, Week 52 ]
    The CGI-C is a clinician's rating of improvement in disease severity.
  • Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 52 ]
    Midbrain atrophy as measured by change in volumetric MRI from baseline to Week 52.
  • Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 52 weeks ]
  • Change from Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [ Time Frame: Baseline, Week 52 ]
    The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.
  • Change from Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: Baseline, Week 52 ]
    The SEADL assesses the subject's ability to perform daily activities.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  • Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 52 weeks ]
  • Change in PSP-RS Total Score from Baseline to Each Observation [ Time Frame: 52 weeks ]
    The PSP-RS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
  • Change in Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: 52 weeks ]
    The SEADL assesses the subject's ability to perform daily activities.
  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [ Time Frame: 52 weeks ]
    The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.
  • Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: 52 weeks ]
    The CGI-S is a clinician's rating of disease severity.
  • Change in Clinical Global Impression of Change (CGI-C) [ Time Frame: 52 weeks ]
    The CGI-C is a clinician's rating of improvement in disease severity.
  • Change in Progressive Supranuclear Palsy Quality of Life (PSP-QoL) [ Time Frame: 52 weeks ]
    The PSP-QoL is a validated patient-reported outcome measure to assess quality of life of patients with PSP.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP).
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
Brief Summary The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Progressive Supranuclear Palsy
Intervention  ICMJE
  • Drug: placebo
    Placebo solution for IV infusion
    Other Name: Tilavonemab
  • Drug: ABBV-8E12
    ABBV-8E12 solution for IV infusion
    Other Name: Tilavonemab
Study Arms  ICMJE
  • Placebo Comparator: Group 3
    Placebo for ABBV-8E12
    Intervention: Drug: placebo
  • Experimental: Group 1
    Dose 1 ABBV-8E12
    Intervention: Drug: ABBV-8E12
  • Experimental: Group 2
    Dose 2 ABBV-8E12
    Intervention: Drug: ABBV-8E12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2019)
378
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
180
Actual Study Completion Date  ICMJE November 20, 2019
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subject with age 40 years or greater at the time of signed consent.
  • Meets the criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome).
  • Presence of PSP symptoms for less than 5 years.
  • Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
  • 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 screening.
  • MMSE score less than 15 at screening.
  • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).
  • Subject 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 subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
  • Subject has had a significant illness or infection requiring medical intervention in the past 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Italy,   Japan,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02985879
Other Study ID Numbers  ICMJE M15-562
2016-001635-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP