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

• Status: Terminated
• Trial end date: 2019-12-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Tilavonemab

Criteria

Inclusion Criteria:

• Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)

• In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)

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

Exclusion Criteria:

• Participants 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)

• Participant 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 participant received his/her last dose of study drug in Study M15-562 (NCT02985879)

• Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations