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Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)

NCT03865732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-06-26

Study results available
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Summary

A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed PCDH19 gene mutation.

Conditions

  • PCDH19-Related Epilepsy

Interventions

DRUG

Ganaxolone

active drug

DRUG

Placebo

inactive

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Maciej Gasior, M.D., Ph.D · Marinus Pharmaceuticals, Inc.

  • Paula Bokesk, M.D., FAAP · Marinus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-17
Primary Completion
2021-01-19
Completion
2022-06-20
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Italy
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT03865732 on ClinicalTrials.gov