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- ||||| ganaxolone IV / Marinus
Trial completion, Trial completion date, Trial primary completion date: RAISE: Randomized Therapy In Status Epilepticus (clinicaltrials.gov) - Sep 25, 2024
P3, N=124, Completed, Sponsor: Marinus Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Apr 2024 | Trial primary completion date: Nov 2024 --> Mar 2024
- | ganaxolone IV / Marinus
Journal: Super Refractory Status Epilepticus Improved After Emergency Use of Ganaxolone: Case Report. (Pubmed Central) - Jun 19, 2024
Emergency use authorization was obtained for intravenous ganaxolone, a neuroactive steroid that is a potent modulator of both synaptic and extrasynaptic GABAA receptors. Following administration of intravenous ganaxolone according to a novel dosing paradigm, the patient showed sustained clinical and electrographic improvement.
- |||| ganaxolone IV / Marinus
Enrollment closed, Trial completion date, Trial primary completion date: RAISE: Randomized Therapy In Status Epilepticus (clinicaltrials.gov) - May 15, 2024
P3, N=124, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
Following administration of intravenous ganaxolone according to a novel dosing paradigm, the patient showed sustained clinical and electrographic improvement. Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Nov 2024 | Trial primary completion date: Oct 2023 --> Nov 2024
- || ganaxolone IV / Marinus
PK/PD data, Journal: Intravenous Ganaxolone: Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability in Healthy Adults. (Pubmed Central) - Mar 4, 2024
No effects on systemic hemodynamics or respiratory functions were reported. Overall, ganaxolone was generally well tolerated at the doses studied and demonstrated pharmacokinetic and pharmacodynamic properties suitable to treat SE.
- ganaxolone IV / Marinus
Intravenous Ganaxolone in Non-Intubated Patients with Refractory Status Epilepticus: Subanalysis of an Open-label, Dose-finding, Phase 2 Trial (Poster Room; In-person) - Aug 15, 2023 - Abstract #NCS2023NCS_642;
- ganaxolone IV / Marinus
Intravenous Ganaxolone in Non-Intubated Patients with Refractory Status Epilepticus: Subanalysis of an Open-label, Dose-finding, Phase 2 Trial (Poster Room; In-person) - Aug 15, 2023 - Abstract #NCS2023NCS_404;
- ||| ganaxolone IV / Marinus
Enrollment open, Trial initiation date: Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE) (clinicaltrials.gov) - Apr 25, 2023
P2, N=120, Recruiting, Sponsor: Marinus Pharmaceuticals
Overall, ganaxolone was generally well tolerated at the doses studied and demonstrated pharmacokinetic and pharmacodynamic properties suitable to treat SE. Not yet recruiting --> Recruiting | Initiation date: Jan 2026 --> Apr 2023
- |||||||| ganaxolone IV / Marinus
New P3 trial: To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE) (clinicaltrials.gov) - Apr 18, 2023
P3, N=70, Not yet recruiting, Sponsor: Marinus Pharmaceuticals
- |||| ganaxolone IV / Marinus
New P2 trial: Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE) (clinicaltrials.gov) - Mar 7, 2023
P2, N=120, Not yet recruiting, Sponsor: Marinus Pharmaceuticals
- ganaxolone IV / Marinus
PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF INTRAVENOUS GANAXOLONE IN HEALTHY ADULT VOLUNTEERS () - Jan 25, 2023 - Abstract #SCCM2023SCCM_1815;
Following IV bolus, GNX was detected in plasma within 5min with onset of PD effects within 15min, with rapid clearance from plasma and reversal of PD effects. GNX was generally well tolerated at the doses studied.
- ganaxolone IV / Marinus
Pharmacokinetic, Pharmacodynamics, and Safety Study of Intravenous Ganaxolone in Healthy Adult Volunteers () - Nov 29, 2022 - Abstract #AES2022AES_637;
Data with adjusted r-square < 0.8 were excluded. Quantitative electroencephalography (qEEG) measures, bispectral index (BIS), modified observers' assessment of alertness and sedation (MOAA/S), plasma concentrations, and safety data were collected.
- ||| ganaxolone IV / Marinus
Trial completion date, Trial primary completion date: RAISE: Randomized Therapy In Status Epilepticus (clinicaltrials.gov) - Oct 21, 2022
P3, N=124, Recruiting, Sponsor: Marinus Pharmaceuticals
Quantitative electroencephalography (qEEG) measures, bispectral index (BIS), modified observers' assessment of alertness and sedation (MOAA/S), plasma concentrations, and safety data were collected. Trial completion date: Mar 2022 --> Oct 2023 | Trial primary completion date: Jan 2022 --> Oct 2023
- || ganaxolone IV / Marinus
P2 data, Clinical Trial,Phase II, Journal: Intravenous Ganaxolone for the Treatment of Refractory Status Epilepticus: Results from an Open-Label, Dose-Finding, Phase 2 Trial. (Pubmed Central) - Sep 21, 2022
Trial completion date: Mar 2022 --> Oct 2023 | Trial primary completion date: Jan 2022 --> Oct 2023 IV ganaxolone achieved rapid and durable seizure control in patients with RSE, and showed acceptable safety and tolerability.
- ganaxolone IV / Marinus
Utilization of Quantitative EEG Spectral Analysis to Characterize IV Ganaxolone PK/PD Properties in Refractory Status Epilepticus (RSE) () - Dec 12, 2021 - Abstract #AES2021AES_1261;
P2
IV ganaxolone achieved rapid and durable seizure control in patients with RSE, and showed acceptable safety and tolerability. This analysis of PK/PD characteristics of IV ganaxolone shows changes in quantitative EEG measures which correlate with initial serum ganaxolone levels and SE cessation in patients with RSE.
- ganaxolone IV / Marinus
IV Ganaxolone in Pediatric Super-Refractory Status Epilepticus: Two Case Presentations () - Dec 12, 2021 - Abstract #AES2021AES_837;
Seizure control was maintained after transitioning to enteric ganaxolone. Further investigation of ganaxolone as a treatment for SRSE is warranted.
- ganaxolone IV / Marinus
The Use of Quantitative EEG Spectral Analysis to Characterize IV Ganaxolone PK/PD characteristics in Patients with Refractory Status Epilepticus () - Sep 10, 2021 - Abstract #NCS2021NCS_454;
P2
A significant positive linear correlation was found between the suppression ratio and serum ganaxolone levels with r-squared greater than 0.87 in 4 out of 5 patients. Conclusions This preliminary analysis suggests that PK/PD qualities of IV ganaxolone could be successfully characterized by quantitative EEG measures which closely correlate with clinical observations.
- ganaxolone IV / Marinus
Intravenous Formulation of Ganaxolone for the Treatment of Refractory Status Epilepticus: Safety Analysis of the Renal Function in a Phase 2 Open-Label, Dose-Ranging Study () - Sep 10, 2021 - Abstract #NCS2021NCS_205;
None of the patients in this study met this definition during or for four weeks after ganaxolone infusion. A Phase 3 study of IV ganaxolone in RSE is currently enrolling in the U.S.
- ganaxolone IV / Marinus
[VIRTUAL] The use of high dose ganaxolone as a late adjunctive therapy in super refractory status epilepticus () - Mar 18, 2021 - Abstract #AAN2021AAN_1755;
Ganaxolone IV revealed a robust initial EEG response in this patient, but did not achieve a durable suppression. Outcomes in NORSE and SRSE is closely linked to underlying etiology, [2,3] more effective treatment strategies may offer greater hope for reducing morbidity and mortality among these patients.
- ganaxolone IV / Marinus
[VIRTUAL] Treatment of Super Refractory Status Epilepticus Using Intravenous Ganaxolone in a Patient with Lennox-Gastaut Syndrome and Angelman Syndrome () - Nov 28, 2020 - Abstract #AES2020AES_1252;
Administration of IV GNX was effective in treating SRSE in this patient with Angelman Syndrome and LGS. Additional pediatric study of IV GNX for SRSE is warrantedFunding: none
- ganaxolone IV / Marinus
[VIRTUAL] IV Ganaxolone in Pediatric Super-Refractory Status Epilepticus: A Single Patient Case Study () - Nov 28, 2020 - Abstract #AES2020AES_1237;
It is a 3β-methylated synthetic analog of the endogenous progesterone metabolite, allopregnanolone. GNX differs from other GABA agents by interacting with both synaptic and extrasynaptic GABAA receptors and at binding sites distinct from benzodiazepines or barbiturates.
- |||| ganaxolone IV / Marinus
Enrollment open: RAISE: Randomized Therapy In Status Epilepticus (clinicaltrials.gov) - Nov 12, 2020
P3, N=124, Recruiting, Sponsor: Marinus Pharmaceuticals
GNX differs from other GABA agents by interacting with both synaptic and extrasynaptic GABAA receptors and at binding sites distinct from benzodiazepines or barbiturates. Not yet recruiting --> Recruiting
- |||| ganaxolone IV / Marinus
Marinus Awarded BARDA Contract to Develop IV Ganaxolone for Treatment of Refractory Status Epilepticus Caused by Nerve Agent Exposure https://t.co/sWhRpyAKcC (Twitter) - Sep 14, 2020
- | ganaxolone IV / Marinus
Trial completion date: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Aug 21, 2020
P2a, N=91, Completed, Sponsor: Marinus Pharmaceuticals
Not yet recruiting --> Recruiting Trial completion date: Jun 2019 --> May 2020
- ||| ganaxolone IV / Marinus
Trial completion, Trial completion date: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - May 28, 2020
P2a, N=91, Completed, Sponsor: Marinus Pharmaceuticals
Trial completion date: Jun 2019 --> May 2020 Active, not recruiting --> Completed | Trial completion date: Mar 2020 --> Jun 2019
- |||||||| ganaxolone IV / Marinus
New P3 trial: RAISE: Randomized Therapy In Status Epilepticus (clinicaltrials.gov) - May 17, 2020
P3, N=168, Not yet recruiting, Sponsor: Marinus Pharmaceuticals
- | ganaxolone IV / Marinus
Trial completion date: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Mar 17, 2020
P2a, N=91, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Mar 2020 --> Jun 2019 Trial completion date: Aug 2019 --> Mar 2020
- ||| ganaxolone IV / Marinus
Trial completion, Enrollment change: Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus (clinicaltrials.gov) - Dec 23, 2019
P2, N=17, Completed, Sponsor: Marinus Pharmaceuticals
Trial completion date: Aug 2019 --> Mar 2020 Recruiting --> Completed | N=250 --> 17
- ganaxolone IV / Marinus
Pharmacokinetic and Pharmacodynamic (PK/PD) Relationship of Intravenous Ganaxolone in Refractory Status Epilepticus (Hall E) - Nov 28, 2019 - Abstract #AES2019AES_1270;
The durability of pharmacological response appears to correlate with GNX exposure and ability to maintain target plasma drug levels for an adequate amount of time. These data demonstrate the potential of a new RSE treatment option and support further clinical evaluation in a larger, randomized-controlled Ph3 study.
- ||| ganaxolone IV / Marinus
Enrollment closed, Enrollment change, Trial primary completion date: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Jun 18, 2019
P2a, N=91, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
These data demonstrate the potential of a new RSE treatment option and support further clinical evaluation in a larger, randomized-controlled Ph3 study. Recruiting --> Active, not recruiting | N=60 --> 91 | Trial primary completion date: Oct 2018 --> Jun 2019
- | ganaxolone IV / Marinus
Trial completion date: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Oct 2, 2018
P2a, N=60, Recruiting, Sponsor: Marinus Pharmaceuticals
Recruiting --> Active, not recruiting | N=60 --> 91 | Trial primary completion date: Oct 2018 --> Jun 2019 Trial completion date: Aug 2018 --> Jun 2019
- | ganaxolone IV / Marinus
Enrollment open, Trial initiation date: Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus (clinicaltrials.gov) - Sep 28, 2018
P2, N=250, Recruiting, Sponsor: Marinus Pharmaceuticals
Trial completion date: Aug 2018 --> Jun 2019 Not yet recruiting --> Recruiting | Initiation date: Nov 2017 --> Feb 2018
- ||| ganaxolone IV / Marinus
Enrollment change: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Mar 6, 2018
P2a, N=60, Recruiting, Sponsor: Marinus Pharmaceuticals
Not yet recruiting --> Recruiting | Initiation date: Nov 2017 --> Feb 2018 N=30 --> 60
- ||||| ganaxolone IV / Marinus
New P2 trial: Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus (clinicaltrials.gov) - Nov 22, 2017
P2, N=250, Not yet recruiting, Sponsor: Marinus Pharmaceuticals
- | ganaxolone IV / Marinus
New P2a trial: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Jul 24, 2017
P2a, N=30, Recruiting, Sponsor: Marinus Pharmaceuticals