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Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

Phase 1
Completed
Conditions
Progressive Supranuclear Palsy (PSP)
Interventions
Drug: ABBV-8E12
Registration Number
NCT03413319
Lead Sponsor
AbbVie
Brief Summary

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3
Inclusion Criteria
  • Subject completed Study C2N-8E12-WW-104 (NCT02494024)
  • Subject was not eligible to enroll in Study M15-562 (NCT02985879)
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Exclusion Criteria
  • Subject weighs less than 35 kg at screening
  • Subject has any contraindication or inability to tolerate brain 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ABBV-8E12ABBV-8E12ABBV-8E12 administered by intravenous (IV) infusion.
Primary Outcome Measures
NameTimeMethod
Adverse EventsFrom first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)

Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

University of California, San /ID# 170113

🇺🇸

La Jolla, California, United States

Texas Health Physicians Group /ID# 170112

🇺🇸

Dallas, Texas, United States

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