A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression
Phase of Trial: Phase II
Latest Information Update: 01 Aug 2017
At a glance
- Drugs Ganaxolone (Primary)
- Indications Postnatal depression
- Focus Adverse reactions; Therapeutic Use
- Acronyms Magnolia
- Sponsors Marinus Pharmaceuticals
- 01 Aug 2017 According to a Marinus Pharmaceuticals media release, the study consists of multiple cohorts of women with a Hamilton Depression Rating Scale (HAMD17) score =26. Patients randomized to the first study cohort will undergo an infusion of either ganaxolone or placebo and will be followed for at least 30 days. Subsequent cohorts could include shorter- or higher-dose IV regimens alone, or in sequential administration with ganaxolone capsules.
- 27 Jun 2017 Status changed from planning to recruiting, according to a Marius Pharmaceuticals media release.
- 05 Jan 2017 According to Marinus Pharmaceuticals media release, company plans to initiate this study in first half of 2017 and expects to announce data from the initial patient cohort(s) in the second half of 2017.