MedTrace Logo

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

NCT03391765 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2021-02-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).

Conditions

  • Progressive Supranuclear Palsy (PSP)

Interventions

DRUG

ABBV-8E12

Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW \>59 kg, 4.7 mL/min or 282 mL/hr.

DRUG

Placebo solution for IV infusion on Day 15

0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW \>59 kg, 4.7 mL/min or 282 mL/hr.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2019-12-13
Completion
2019-12-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03391765 on ClinicalTrials.gov