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A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02985879
First Posted: December 7, 2016
Last Update Posted: October 13, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Condition Intervention Phase
Progressive Supranuclear Palsy Drug: ABBV-8E12 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) Subscale Scores and Visual Analog Scale (VAS) [ Time Frame: 52 weeks ]
    The PSP-QoL is a validated patient-reported outcome measure to assess quality of life of patients with PSP.


Estimated Enrollment: 180
Study Start Date: December 16, 2016
Estimated Study Completion Date: September 3, 2019
Estimated Primary Completion Date: May 18, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Dose 1 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Placebo Comparator: Group 3
Placebo for ABBV-8E12
Drug: Placebo
placebo solution for IV infusion

  Eligibility

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.


Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
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.
  Contacts and Locations
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


Contacts
Contact: AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 40 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02985879     History of Changes
Other Study ID Numbers: M15-562
2016-001635-12 ( EudraCT Number )
First Submitted: December 1, 2016
First Posted: December 7, 2016
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
tauopathy
Steele-Richardson-Olszewski syndrome
PSP

Additional relevant MeSH terms:
Paralysis
Supranuclear Palsy, Progressive
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