Trial intelligence / Profile preview

Rapastinel Open-Label Extension in MDD

NCT03668600Phase 3

Key facts

Status
Terminated
Start
Aug 2018
Primary completion
Jul 2019
Countries
1
Sponsor
Allergan
Modality
Peptides, Small Molecules
Conditions
major depressive disorder (MDD)
01

Overview

Phase 3, open-label, single-arm trial of rapastinel in major depressive disorder (MDD), sponsored by Allergan. Primary endpoint: Treatment Emergent Adverse Events at 45 weeks. Started Aug 2018; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Rapastinel

    Rapastinel 450 mg IV

03

Who it enrols

Adult patients with MDD who completed the lead-in study and showed adequate therapeutic benefit without significant suicide risk.

04

Endpoints

Primary

  • Treatment Emergent Adverse Events

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