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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 : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : June 13, 2020
Estimated Study Completion Date : June 13, 2020


Arm Intervention/treatment
Placebo Comparator: Group 3
Placebo for ABBV-8E12
Drug: placebo
Placebo solution for IV infusion

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

Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion




Primary Outcome Measures :
  1. 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).

  2. Adverse Events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  2. 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.

  3. 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.

  4. Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  5. Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  6. Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 52 weeks ]
  7. 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.

  8. 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.



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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:

  • 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.

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): NCT02985879


  Show 68 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02985879     History of Changes
Other Study ID Numbers: M15-562
2016-001635-12 ( EudraCT Number )
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
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

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:
PSP
Steele-Richardson-Olszewski syndrome
tauopathy

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms