deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka 
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  • ||||||||||  deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia (clinicaltrials.gov) -  Jun 22, 2023   
    P2/3,  N=136, Terminated, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Dec 2023 N=370 --> 136 | Trial completion date: Nov 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> May 2023; Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.
  • ||||||||||  deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
    Trial primary completion date:  Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (clinicaltrials.gov) -  Mar 27, 2023   
    P3,  N=1200, Recruiting, 
    N=370 --> 136 | Trial completion date: Nov 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> May 2023; Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility. Trial primary completion date: Oct 2023 --> Jul 2025
  • ||||||||||  Review, Journal:  Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China. (Pubmed Central) -  Dec 3, 2022   
    The reuse of drugs or combinations currently under investigation for the psychiatric treatment of Alzheimer's disease, including AXS-05, AVP-786, nabilone, brexpiprazole, methylphenidate, and pimavanserin, could provide physicians with additional treatment options. Although most of these drugs have not been explored in China yet, due to the current development trend in this field in China, it is expected that China will be involved in research on these drugs in the future.
  • ||||||||||  Journal:  Clinical Application and Synthesis Methods of Deuterated Drugs. (Pubmed Central) -  Nov 24, 2022   
    In 2017, austedo was approved by the FDA as a new drug for Huntington's disease in the United States, the first deuterium drug to be marketed worldwide...In addition, BMS-986165, RT001, ALK-001, HC-1119, AVP-786 and other drugs are in phase Ⅲ clinical studies, and some solid deuterium compounds have entered phase I and Ⅱclinical trials...In this paper, the research and development of deuterated drugs are reviewed, and the influence of deuterium modification on drugs, the advantages of deuterium strategies and the synthesis strategies of deuterated drugs are mainly introduced. Hoping to provide references for clinical application, the discovery of new deuterium chemical entities and research and development of new deuterated drugs.
  • ||||||||||  deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
    Trial completion date, Trial primary completion date:  Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia (clinicaltrials.gov) -  Jul 12, 2022   
    P2/3,  N=370, Recruiting, 
    In conclusion, there is hope for new treatments in uni- and bipolar depression, as it became clear, after almost 7 decades of monoamine-modulating antidepressants, that new pathogenetic pathways should be targeted to increase the response rate in this population. Trial completion date: Aug 2022 --> Nov 2024 | Trial primary completion date: Jul 2022 --> Oct 2024
  • ||||||||||  Review, Journal:  Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status. (Pubmed Central) -  Jan 7, 2022   
    Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.
  • ||||||||||  dextromethorphan deuterated/quinidine ultra-low dose (AVP-786) / Otsuka, ANAVEX 3-71 / Anavex, edonerpic (T-817MA) / Fujifilm Holdings
    Journal:  The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's. (Pubmed Central) -  Dec 16, 2021   
    AF710B, T-817 MA, and ANAVEX2-73 are some of the σ-1R agonists which have shown promising results and have entered clinical trials...The future of AD treatment could involve the combined targeting the σ-1R and autophagy activation. We suggest that future studies investigate the link between autophagy the σ-1R and AD.
  • ||||||||||  dextromethorphan deuterated/quinidine ultra-low dose (AVP-786) / Otsuka
    Journal:  AVP-786 as a promising treatment option for Alzheimer's Disease including agitation. (Pubmed Central) -  Feb 23, 2021   
    Future phase III studies should use innovative study designs such as the Sequential Parallel Comparison Design to mitigate high placebo response, and the Cohen-Mansfield Agitation Inventory for agitation assessment. They should also include positron emission tomography studies to assess occupancy of various receptors in the brain after AVP-786 is administered.
  • ||||||||||  Journal:  Glutamatergic Modulators in Depression. (Pubmed Central) -  Jun 7, 2019   
    These results have prompted the repurposing or development of other glutamatergic modulators, both as monotherapy or adjunctive to other therapies. Here, we highlight the evidence supporting the antidepressant effects of various glutamatergic modulators, including (1) broad glutamatergic modulators (ketamine, esketamine, dextromethorphan, dextromethorphan-quinidine [Nuedexta], AVP-786, nitrous oxide [N2O], AZD6765), (2) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (CP-101,606/traxoprodil, MK-0657 [CERC-301]), (3) glycine-site partial agonists (D-cycloserine, GLYX-13, sarcosine, AV-101), and (4) metabotropic glutamate receptor modulators (AZD2066, RO4917523/basimglurant, JNJ40411813/ADX71149, R04995819 [RG1578]).
  • ||||||||||  deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
    Enrollment closed, Trial primary completion date:  Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type (clinicaltrials.gov) -  May 23, 2019   
    P3,  N=522, Active, not recruiting, 
    Here, we highlight the evidence supporting the antidepressant effects of various glutamatergic modulators, including (1) broad glutamatergic modulators (ketamine, esketamine, dextromethorphan, dextromethorphan-quinidine [Nuedexta], AVP-786, nitrous oxide [N2O], AZD6765), (2) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (CP-101,606/traxoprodil, MK-0657 [CERC-301]), (3) glycine-site partial agonists (D-cycloserine, GLYX-13, sarcosine, AV-101), and (4) metabotropic glutamate receptor modulators (AZD2066, RO4917523/basimglurant, JNJ40411813/ADX71149, R04995819 [RG1578]). Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2019 --> Sep 2019
  • ||||||||||  deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
    Trial completion date, Trial termination, Trial primary completion date:  Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder (clinicaltrials.gov) -  Jan 31, 2019   
    P2,  N=10, Terminated, 
    Trial completion date: Mar 2021 --> Jun 2022 | Trial primary completion date: Mar 2021 --> Jun 2022 Trial completion date: Sep 2020 --> Dec 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2020 --> Dec 2018; Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.