A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP).

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Brief Title

A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

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

Brief Summary

      The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics
      of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
    

Detailed Description

      This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter
      study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind
      treatment period, and a post-treatment follow-up period of approximately 20 weeks following
      last study drug administration (for those participants who prematurely discontinued from
      treatment, declined to participate in or did not qualify for participation in a long term
      extension [LTE] study). At the end of the treatment period, extended treatment was available
      for eligible participants who completed the 52-week treatment period and entered the separate
      long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study
      (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK)
      assessments in the first 30 participants enrolled into the global study from countries other
      than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants
      enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in
      the global study not participating in Cohort 1 or Cohort J1.

      This study was prematurely discontinued because the program for progressive supranuclear
      palsy was discontinued due to lack of efficacy of study drug.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score

Secondary Outcome

 Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

Condition

Progressive Supranuclear Palsy

Intervention

Placebo

Study Arms / Comparison Groups

 Placebo
Description:  0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

378

Start Date

December 12, 2016

Completion Date

November 20, 2019

Primary Completion Date

November 20, 2019

Eligibility Criteria

        Key Inclusion Criteria:

          -  Male or female participant with age 40 years or greater at the time of signed consent

          -  Meets the criteria for possible or probable progressive supranuclear palsy (PSP;
             Steele-Richardson-Olszewski Syndrome)

          -  Presence of PSP symptoms for less than 5 years

          -  Participant is able to walk 5 steps with minimal assistance (stabilization of one arm
             or use of cane/walker)

          -  Participant has an identified, reliable, study partner (e.g., caregiver, family
             member, social worker, or friend)

        Key Exclusion Criteria:

          -  Participants who weigh less than 44 kg (97 lbs) at screening

          -  Mini-Mental State Examination (MMSE) score less than 15 at screening

          -  Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

          -  Participant 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 participant has a history of or currently has schizophrenia, schizoaffective
             disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental
             Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10)
             criteria

          -  Participant has had a significant illness or infection requiring medical intervention
             in the past 30 days
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

AbbVie Inc., , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT02985879

Organization ID

M15-562

Secondary IDs

2016-001635-12

Responsible Party

Sponsor

Study Sponsor

AbbVie


Study Sponsor

AbbVie Inc., Study Director, AbbVie


Verification Date

February 2021