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  • ||||||||||  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, 
    Following mutations were revealed in PARP1 (NM_001618: c.2285TG, p.K135R), MTRR (NM_024010: c.147A>G, p.I49M) and two sorts of mutations in structure of KMT2C gene (NM_170606: c.2447_2448insA (c.2447dupA), p.Y816fs and NM_170606: c.1042G>A, p.D348N) for the first time in MMTVT. Trial completion date: Jun 2019 --> May 2020
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    [VIRTUAL] Clinical and molecular complexity of X-linked clustering epilepsy, a disorder of cellular mosaics (Virtual Session Room 5) -  Aug 4, 2020 - Abstract #ESHG2020ESHG_329;    
    Thirdly, using patient-derived skin fibroblast cell lines we identified genetic (mRNA, protein) and epigenetic (methylation) biomarkers of the penetrance of XCE even among discordant monozygotic twins. Our research set foundations of a Phase III international clinical trial of ganaxolone in XCE.
  • ||||||||||  Zulresso (brexanolone) / Sage Therapeutics, ganaxolone oral (CCD-1042) / Marinus
    Journal:  Isobolographic Analysis of Antiseizure Activity of the GABA-A Receptor-Modulating Synthetic Neurosteroids Brexanolone and Ganaxolone with Tiagabine and Midazolam. (Pubmed Central) -  Jul 7, 2020   
    SIGNIFICANCE STATEMENT: This paper investigates for the first time the potential synergistic interactions between two neurosteroids with anticonvulsant properties, allopregnanolone (brexanolone) and the very similar synthetic analog, ganaxolone, and two conventional antiepileptic drugs active at GABA-A receptors, the GABA reuptake inhibitor, tiagabine, and a benzodiazepine, midazolam. The results demonstrate a synergistic protective effect of neurosteroid-tiagabine combinations, as well as neurosteroid-midazolam regimens in seizure models.
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Review, Journal:  Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development. (Pubmed Central) -  Jul 4, 2020   
    SAGE-217, an allopregnanolone analog, with oral bioavailability, was recently tested in a randomized, double-blind, placebo-controlled phase III study in severe postpartum depression, with reportedly positive results. Finally, a 3β-methylated synthetic analog of allopregnanolone, ganaxolone, is being tested in both intravenous and oral forms, in randomized, double-blind, placebo-controlled phase II studies in severe postpartum depression.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Enrollment closed:  Marigold: Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder (clinicaltrials.gov) -  Jun 28, 2020   
    P3,  N=102, Active, not recruiting, 
    Finally, a 3β-methylated synthetic analog of allopregnanolone, ganaxolone, is being tested in both intravenous and oral forms, in randomized, double-blind, placebo-controlled phase II studies in severe postpartum depression. Recruiting --> Active, not recruiting
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Enrollment open:  Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B) (clinicaltrials.gov) -  May 31, 2020   
    P2,  N=30, Recruiting, 
    Finally, should rigorous studies confirm an antidepressant effect, it will be important to identify subsets of women who respond (e.g. women with neuroactive steroid dysregulation) and mechanisms of action. Not yet recruiting --> Recruiting
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Trial completion:  A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) -  May 17, 2020   
    P2,  N=84, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Mar 2020 --> Jun 2019 Active, not recruiting --> Completed
  • ||||||||||  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, 
    These findings indicate the potential to develop personalized gender-specific neurosteroid treatments for SE and epilepsy in men and women, including catamenial epilepsy. Trial completion date: Aug 2019 --> Mar 2020
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Journal:  Analysis of mutations in the FOXI1 and KCNJ10 genes in infants with a single-allele SLC26A4 mutation. (Pubmed Central) -  Jan 1, 2020   
    Eight individuals with a DHMs all passed universal newborn hearing screening, and all were found to have normal hearing. These data suggest that individuals with an SLC26A4 single-allele mutation, combined with FOXI1 or KCNJ10 gene mutations, do not suffer hearing loss during infancy, though this finding is worthy of further follow-up and in-depth discussion.
  • ||||||||||  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, 
    These pharmacodynamic interactions have clinical implications in neurosteroid therapy for brain conditions associated with zinc fluctuations. Recruiting --> Completed | N=250 --> 17
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Journal:  New antiepileptic drugs (Pubmed Central) -  Nov 2, 2019   
    Cannabidiol and fenfluramine are useful in the treatment of Dravet or Lennox Gastaut syndrome. Allopregnenolona and ganaxolone showed good efficacy in status epilepticus and could play an important future role in this clinical scenario.
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus, Afinitor (everolimus) / Novartis
    Clinical, Journal:  Antiepileptic drugs in clinical development: differentiate or die? (Pubmed Central) -  Jul 11, 2019   
    Substantial improvements in the efficacy, specifically as pharmacological treatment of drug-resistant epilepsy is regarded, are not expected. New drugs should be developed to specifically target the biochemical alteration which characterizes the underlying disease and also include targets that contribute to epileptogenesis in relevant epilepsy models.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Enrollment closed, Trial completion date:  Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) -  Jul 5, 2019   
    P2,  N=30, Active, not recruiting, 
    New drugs should be developed to specifically target the biochemical alteration which characterizes the underlying disease and also include targets that contribute to epileptogenesis in relevant epilepsy models. Completed --> Active, not recruiting | Trial completion date: Jan 2019 --> Jun 2021
  • ||||||||||  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, 
    Completed --> Active, not recruiting | Trial completion date: Jan 2019 --> Jun 2021 Recruiting --> Active, not recruiting | N=60 --> 91 | Trial primary completion date: Oct 2018 --> Jun 2019
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Enrollment closed, Enrollment change:  A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) -  Jun 12, 2019   
    P2,  N=84, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=60 --> 91 | Trial primary completion date: Oct 2018 --> Jun 2019 Recruiting --> Active, not recruiting | N=58 --> 84
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Trial completion date, Trial primary completion date:  A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) -  Jun 6, 2019   
    P2,  N=58, Recruiting, 
    Recruiting --> Active, not recruiting | N=58 --> 84 Trial completion date: Jan 2019 --> Sep 2019 | Trial primary completion date: Jan 2019 --> Jun 2019
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Review, Journal:  Reduced Neurosteroid Exposure Following Preterm Birth and Its' Contribution to Neurological Impairment: A Novel Avenue for Preventative Therapies. (Pubmed Central) -  Jun 4, 2019   
    ...Allopregnanolone is a key neuroprotective fetal neurosteroid which has promyelinating effects in the developing brain...The early loss of this intrauterine neurotrophic support following preterm birth may be pivotal to development of neurodevelopmental morbidity. Thus, restoring the in utero neurosteroid environment for preterm neonates may represent a new and clinically feasible treatment option for promoting better trajectories of myelination and brain development, and therefore reducing neurodevelopmental disorders in children born preterm.
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Clinical, Journal:  Patient with multiple acyl-CoA dehydrogenase deficiency disease and ETFDH mutations benefits from riboflavin therapy: a case report. (Pubmed Central) -  May 30, 2019   
    Thus, restoring the in utero neurosteroid environment for preterm neonates may represent a new and clinically feasible treatment option for promoting better trajectories of myelination and brain development, and therefore reducing neurodevelopmental disorders in children born preterm. Our findings support the role of WES as an effective tool in the diagnosis of highly heterogeneous disease and this has important implications in the therapeutic strategy of LSM treatment.
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Clinical, Journal, BRCA Biomarker:  Searching for new breast cancer-associated genes. ABRAXAS1 gene mutations in the group of BRCA1-negative patients. (Pubmed Central) -  May 24, 2019   
    ...In 96 BRCA1-negative patients two missense variants: c.422C>T and c.1042G>A as well as two intronic variants: IVS3-34G>A, IVS3-44T>C were detected in the ABRAXAS1 gene...IVS3-44T>C was found more frequently in the control group (15/93) than in the tested group (1/85), OR 0.062; 95% CI: 0.008-0.480, p = 0.007, which may suggest protective properties of this variant against tumorigenicity. The data obtained from the present study suggest the necessity for further research to be conducted on the ABRAXAS1 gene in relation to hereditary predisposition to breast cancer.
  • ||||||||||  ganaxolone oral (CCD-1042) / Marinus
    Journal:  A Novel Missense Mutation in SLC5A5 Gene in a Sudanese Family with Congenital Hypothyroidism. (Pubmed Central) -  Apr 26, 2019   
    ...The two siblings were treated with levothyroxine and had normal development...This identified a novel homozygous missense mutation in the SLC5A5 gene-c.1042T>G, p.Y348D-which was subsequently confirmed by Sanger sequencing...The mutation is located in the TMS IX of the NIS protein which is essential for NIS function. Low iodine intake in Sudan is considered to affect severity of hypothyroidism in the patients.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus, NN1213 / Novo Nordisk
    Trial completion, Trial completion date, Trial primary completion date:  Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone (clinicaltrials.gov) -  Sep 14, 2018   
    P=N/A,  N=10, Completed, 
    Not yet recruiting --> Recruiting | Initiation date: Nov 2017 --> Feb 2018 Recruiting --> Completed | Trial completion date: Jan 2019 --> Jan 2018 | Trial primary completion date: Aug 2018 --> Jan 2018
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Trial completion:  Ganaxolone Treatment in Children With Fragile X Syndrome (clinicaltrials.gov) -  Mar 22, 2018   
    P2,  N=59, Completed, 
    Recruiting --> Completed | Trial completion date: Jan 2019 --> Jan 2018 | Trial primary completion date: Aug 2018 --> Jan 2018 Active, not recruiting --> Completed