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Brexanolone phase 3 trials (studies 202B and 202C)

Two trials that tested a single 60-hour drip of brexanolone against a placebo in women with postpartum depression: one in women with severe depression and one in women with moderate depression. Women in the United States took part: 138 in the first trial and 108 in the second. The US 2019 label for Zulresso names them as its two efficacy studies.

Also called 547-PPD-202B · 547-PPD-202C

  • Study
  • In this atlas

Overview

Design
Two multicentre, double-blind, randomised, placebo-controlled phase 3 trials of a single 60-hour intravenous infusion. Study 1 (severe, HAM-D 26 or more): brexanolone 90 µg/kg per hour, 60 µg/kg per hour or placebo (1:1:1). Study 2 (moderate, HAM-D 20 to 25): brexanolone 90 µg/kg per hour or placebo (1:1). Registry masking: quadruple.
Phase
Phase 3
Enrolled
  • 138 participants (study 202B, ClinicalTrials.gov gives no unit) (enrolled count) (A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B), retrieved )
  • 108 participants (study 202C, ClinicalTrials.gov gives no unit) (enrolled count) (A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C), retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT02942004
  • NCT NCT02942017
Started
Not reported
Primary completion
Not reported
Completion
Not reported
Countries
United States (A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B), retrieved )
Care setting
Clinical research centres and specialised psychiatric units: 30 sites in the USA, as reported in the paper abstract. (Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT02942004 (547-PPD-202B, severe, registry enrolment 138) and NCT02942017 (547-PPD-202C, moderate, registry enrolment 108), both phase 3, randomised, double-blind, placebo-controlled, lead sponsor Supernus Pharmaceuticals (industry; the abstract names Sage Therapeutics as funder), both COMPLETED. The paper abstract reports 30 clinical research centres and specialised psychiatric units in the USA, women aged 18 to 45 years and up to 6 months post partum, 138 randomised in study 1 (45, 47 and 46 across the 90 µg/kg per hour, 60 µg/kg per hour and placebo arms) and 108 in study 2 (54 and 54), follow-up to day 30, and a primary endpoint of HAM-D total score change at 60 hours. The two trials have different start and completion dates, so the study dates are left to the registry records and not shown here. The main paper has a published erratum that was not read. Findings are in the claims on the brexanolone and Zulresso pages; no structured findings are recorded because the atlas has no outcome record for HAM-D change.

Arms

  • Study 202B: brexanolone 90 µg/kg per hour

    Intervention Brexanolone

    Titrated to a target of 90 µg/kg per hour over a 60-hour infusion (registry arm SAGE-547 90 µg/kg/h).

  • Study 202B: brexanolone 60 µg/kg per hour

    Intervention Brexanolone

    Titrated to a target of 60 µg/kg per hour over a 60-hour infusion (registry arm SAGE-547 60 µg/kg/h).

  • Study 202B: placebo

    Intervention None named

    Matching placebo infusion for 60 hours.

  • Study 202C: brexanolone 90 µg/kg per hour

    Intervention Brexanolone

    Titrated to a target of 90 µg/kg per hour over a 60-hour infusion (registry arm SAGE-547 90 µg/kg/h).

  • Study 202C: placebo

    Intervention None named

    Matching placebo infusion for 60 hours.

Findings

No findings are published for this study.

Record details

Record id
maternal:hummingbird-brexanolone-trials
Content hash
96c6f013e88659bbe5da37981da98d1ea5447a4ac377fe431d2383bf899a908c