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ClinicalTrials.gov public records Last synced Oct 18, 2026, 4:28 AM EDT

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Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Ganaxolone Clear all
Terminated Phase 2 Interventional Results available

Open-label Extension to Protocol 1042-0500

NCT00442104
View directory record Official record
Conditions
Infantile Spasms
Interventions
Ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
4 Months to 24 Months
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
14
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Miami, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated May 28, 2024 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

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

NCT03865732
View directory record Official record
Conditions
PCDH19-Related Epilepsy
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
1 Year to 17 Years · Female only
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
6
States / cities
Little Rock, Arkansas • Los Angeles, California • San Francisco, California + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 26, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Not yet recruiting Phase 2 Interventional

Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism

NCT07635862
View directory record Official record
Conditions
Autism in Children, Autistic Disorder in Children and Adolescents, Autism Spectrum Disorder
Interventions
Ganaxolone (Ztalmy), Placebo
Drug
Lead sponsor
Stanford University
Other
Eligibility
5 Years to 17 Years
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2027 – 2030
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 3 Interventional Results available

Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

NCT01963208
View directory record Official record
Conditions
Drug Resistant Partial Onset Seizure
Interventions
ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
405 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
33
States / cities
Birmingham, Alabama • Phoenix, Arizona • Sun City, Arizona + 25 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

NCT03350035
View directory record Official record
Conditions
Status Epilepticus, Convulsive Status EPILEPTICUS, Non Convulsive Status Epilepticus, Epilepsy
Interventions
IV Ganaxolone active, IV Placebo, non-active
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
12 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
8
States / cities
Wilmington, Delaware • Miami, Florida • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Mar 9, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

NCT03460756
View directory record Official record
Conditions
Depressive Disorder, Depression, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorder, Pregnancy Complications, Postpartum Blues, PPD, Postpartum Disorder
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years to 48 Years · Female only
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
33
States / cities
Glendale, California • Lemon Grove, California • Long Beach, California + 29 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 3 Interventional Results available

Randomized Therapy In Status Epilepticus

NCT04391569
View directory record Official record
Conditions
Status Epilepticus
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
12 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
64
States / cities
Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 46 more
Source: ClinicalTrials.gov public record
Updated May 29, 2025 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Not applicable Interventional Results available

Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone

NCT02900092
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Ganaxolone
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
50 Years to 75 Years · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 18, 2019 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)

NCT04285346
View directory record Official record
Conditions
Tuberous Sclerosis
Interventions
Ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
2 Years to 65 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
7
States / cities
Los Angeles, California • Palo Alto, California • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 4, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies

NCT02358538
View directory record Official record
Conditions
Epilepsy
Interventions
Ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
2 Years to 18 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
9
States / cities
Phoenix, Arizona • Sacramento, California • San Francisco, California + 6 more
Source: ClinicalTrials.gov public record
Updated Mar 21, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

NCT03228394
View directory record Official record
Conditions
Depression, Depressive Disorder, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorders, Puerperal Disorders, Pregnancy Complications, Postpartum, PPD
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
91 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
16
States / cities
Little Rock, Arkansas • Costa Mesa, California • Lemon Grove, California + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03572933
View directory record Official record
Conditions
CDKL5 Deficiency Disorder
Interventions
ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
2 Years to 21 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
17
States / cities
Phoenix, Arizona • Los Angeles, California • Aurora, Colorado + 14 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Open-label Extension to Protocol 1042-0600

NCT00512317
View directory record Official record
Conditions
Epilepsies, Partial
Interventions
ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years to 69 Years
Enrollment
123 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
25
States / cities
Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 22 more
Source: ClinicalTrials.gov public record
Updated Jan 17, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms

NCT00441896
View directory record Official record
Conditions
Infantile Spasms
Interventions
Ganaxolone, Placebo
Drug · Other
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
4 Months to 24 Months
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
15
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Miami, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

NCT01857531
View directory record Official record
Conditions
Smoking Cessation
Interventions
Ganaxolone, Nicotine Patch
Drug
Lead sponsor
Jed E. Rose
Other
Eligibility
18 Years to 65 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
4
States / cities
Charlotte, North Carolina • Durham, North Carolina • Raleigh, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2014 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 3 Interventional Results available

Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

NCT05323734
View directory record Official record
Conditions
Tuberous Sclerosis Complex
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
1 Year to 65 Years
Enrollment
129 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
23
States / cities
Little Rock, Arkansas • Los Angeles, California • Orange, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 11, 2025 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Ganaxolone in Posttraumatic Stress Disorder (PTSD)

NCT01339689
View directory record Official record
Conditions
PTSD
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
8
States / cities
San Diego, California • Washington D.C., District of Columbia • Boston, Massachusetts + 5 more
Source: ClinicalTrials.gov public record
Updated Dec 29, 2022 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

NCT01002820
View directory record Official record
Conditions
Epilepsy, Complex Partial
Interventions
ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
7
States / cities
Los Angeles, California • Lexington, Kentucky • Albany, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2022 · Synced Oct 18, 2026, 4:28 AM EDT
Terminated Phase 3 Interventional Results available

A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures

NCT02519439
View directory record Official record
Conditions
Drug Resistant Partial Onset Seizure
Interventions
ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
5
States / cities
Santa Monica, California • Lexington, Kentucky • Golden Valley, Minnesota + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Terminated Phase 3 Interventional Results available

Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

NCT05604170
View directory record Official record
Conditions
Tuberous Sclerosis Complex
Interventions
Ganaxolone
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
1 Year to 65 Years
Enrollment
117 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
20
States / cities
Little Rock, Arkansas • Los Angeles, California • Orange, California + 17 more
Source: ClinicalTrials.gov public record
Updated Oct 1, 2025 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

NCT00465517
View directory record Official record
Conditions
Partial Epilepsy, Catamenial Epilepsy
Interventions
Ganaxolone, Placebo
Drug · Other
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
18 Years to 69 Years
Enrollment
147 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
27
States / cities
Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 23 more
Source: ClinicalTrials.gov public record
Updated Mar 15, 2023 · Synced Oct 18, 2026, 4:28 AM EDT
Completed Phase 2 Interventional Results available

Ganaxolone Treatment in Children With Fragile X Syndrome

NCT01725152
View directory record Official record
Conditions
Fragile x Syndrome
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
6 Years to 17 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Apr 10, 2023 · Synced Oct 18, 2026, 4:28 AM EDT