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

  • Interventional
  • Not Recruiting
  • NCT03391765
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
40 Years and up

Accepting Healthy Volunteers?
No

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.
  • Progressive Supranuclear Palsy (PSP)

At a Glance

National Government IDNCT03391765

IRB#IRB17-1545

Lead SponsorAbbVie

Lead PhysicianTao Xie

Collaborator(s)N/A

EligibilityAll
40 Years and up
Not Recruiting