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

Progressive Supranuclear Palsy (PSP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413319
• Other study ID #: M16-948
• Status: Completed
• Phase: Phase 1
• Start date: April 17, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: December 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject completed Study C2N-8E12-WW-104 (NCT02494024)

• Subject was not eligible to enroll in Study M15-562 (NCT02985879)

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

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy (PSP)
• Supranuclear Palsy, Progressive

Intervention

Drug:
• ABBV-8E12
Solution for infusion

Locations

Country	Name	City	State
United States	Texas Health Physicians Group /ID# 170112	Dallas	Texas
United States	University of California, San /ID# 170113	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.	From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)