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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03572933

Public ClinicalTrials.gov record NCT03572933. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 1:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03572933
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Marinus Pharmaceuticals
Industry
Enrollment
101 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2018 (Actual)
Primary completion
Jul 31, 2020 (Actual)
Completion
May 28, 2021 (Actual)
Last update posted
Apr 14, 2023

2018 – 2021

United States locations

U.S. sites
17
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
Marinus Research Site Phoenix Arizona 85016 —
Marinus Research Site Los Angeles California 90095-1742 —
Marinus Research Site Aurora Colorado 80045 —
Marinus Research Site Gulf Breeze Florida 32561 —
Marinus Research Site Orlando Florida 32819 —
Marinus Research Site Norcross Georgia 30093 —
Marinus Research Site Chicago Illinois 60612-3852 —
Marinus Research Site Iowa City Iowa 52242 —
Marinus Research Site Boston Massachusetts 02115 —
Marinus Research Site Rochester Minnesota 55905 —
Marinus Research Site St Louis Missouri 63130 —
Marinus Research Site Livingston New Jersey 07039 —
Marinus Research Site Cleveland Ohio 44195 —
Marinus Research Site Philadelphia Pennsylvania 19104-4318 —
Marinus Research Site Pittsburgh Pennsylvania 15224 —
Marinus Research Site Fort Worth Texas 76104 —
Marinus Research Site Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03572933, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2023 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03572933 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →