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Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder

NCT03572933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-04-14

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 children and young adults with genetically confirmed CDKL5 gene mutation.

Conditions

  • CDKL5 Deficiency Disorder

Interventions

DRUG

ganaxolone

active drug

DRUG

Placebo

inactive

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joseph Hulihan, MD · Marinus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2020-07-31
Completion
2021-05-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Israel
  • Italy
  • Poland
  • Russia
  • United Kingdom

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 NCT03572933 on ClinicalTrials.gov