ecopipam (PSYRX 101) / Paragon Biosci 
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  • ||||||||||  risperidone / Generic mfg., ziprasidone / Generic mfg.
    Review, Journal:  Current Management of Tics and Tourette Syndrome: Behavioral, Pharmacologic, and Surgical Treatments. (Pubmed Central) -  Oct 30, 2021   
    Pharmacological therapies, such as alpha agonists, topiramate, and vesicular monoamine transport type 2 inhibitors, are generally used as first-line therapies in patients with troublesome tics that are not controlled by behavioral therapy or when the latter is not available or accessible...Second-line therapy includes antipsychotics, such as fluphenazine, aripiprazole, risperidone, and ziprasidone...There is promise in ongoing clinical trials with D1 receptor antagonist ecopipam and other experimental therapeutics. Patients with tics that are refractory to conventional treatments may be candidates for deep brain stimulation, but further studies are needed to determine the optimal target selection.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  Altered Functional Connectivity of the Orbital Cortex and Striatum Associated with Catalepsy Induced by Dopamine D1 and D2 Antagonists. (Pubmed Central) -  Oct 16, 2021   
    Moreover, the distinct mechanisms in the SCH39166- and raclopride-induced cataleptic behaviors are the decreased functional connectivity between three areas above and the cortical amygdala, and between three areas above and the anterior cingulate cortex, respectively. Thus, the alterations of functional connectivity in diverse brain regions, including the ORB, provide new insights on the mechanism underlying drug-induced movement disorders.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial completion:  D1AMOND: Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (clinicaltrials.gov) -  Oct 13, 2021   
    P2b,  N=153, Completed, 
    Thus, the alterations of functional connectivity in diverse brain regions, including the ORB, provide new insights on the mechanism underlying drug-induced movement disorders. Active, not recruiting --> Completed
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  The non-selective adenosine antagonist theophylline reverses the effects of dopamine antagonism on tremor, motor activity and effort-based decision-making. (Pubmed Central) -  Apr 14, 2021   
    Theophylline (3.75-30.0 mg/kg, IP) reversed tremulous jaw movements (TJMs), catalepsy, and locomotor suppression induced by the dopamine D2 antagonist pimozide...Parallel studies assessed the ability of theophylline (5.0-20.0 mg/kg, IP) to reverse the changes in effort-related choice behavior induced by the dopamine D1 antagonist ecopipam (0.2 mg/kg, IP) and the D2 antagonist haloperidol (0.1 mg/kg, IP)...However, it was unable to reverse the effects of the D1 antagonist. Overall, the effects of theophylline resembled those previously reported for adenosine A antagonists, and suggest that theophylline could be clinically useful for the treatment of motor and motivational symptoms in humans.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  Dopamine D or D receptor modulators prevent morphine tolerance and reduce opioid withdrawal symptoms. (Pubmed Central) -  Mar 31, 2021   
    Withdrawal symptoms peaked at 48 h and were decreased in rats receiving either combination compared to morphine alone. The data suggests that adjunct therapy with dopamine D or D receptor preferring modulators prevents morphine tolerance and reduces the duration of morphine withdrawal symptoms, and thus this combination has potential for long-term pain management therapy.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Enrollment open:  Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates (clinicaltrials.gov) -  Mar 23, 2021   
    P1,  N=48, Recruiting, 
    The data suggests that adjunct therapy with dopamine D or D receptor preferring modulators prevents morphine tolerance and reduces the duration of morphine withdrawal symptoms, and thus this combination has potential for long-term pain management therapy. Not yet recruiting --> Recruiting
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Enrollment open:  Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely) (clinicaltrials.gov) -  Oct 8, 2020   
    P2,  N=68, Recruiting, 
    Together, our results suggest that dopamine transmission through Drd1 and Drd2 in NAc core is critical to the incubation of methamphetamine craving after voluntary abstinence. Not yet recruiting --> Recruiting
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial completion date, Trial primary completion date:  D1AMOND: Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (clinicaltrials.gov) -  Oct 7, 2020   
    P2b,  N=150, Recruiting, 
    Trial completion date: Dec 2021 --> Nov 2022 | Trial primary completion date: Sep 2021 --> Oct 2022 Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Sep 2020 --> Sep 2021
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    [VIRTUAL] Reduced cerebellum volume and ataxia-like motoric phenotype in transgenic mouse, carrier of human CYP2C19 gene (Poster Area) -  Aug 5, 2020 - Abstract #ECNP2020ECNP_691;    
    Beam walking test was repeated after treatment with dopaminergic receptor antagonists, Ecopipam (0.1 mg/kg) and Raclopride (0.25 mg/kg) as a follow-up...Conclusion Ataxia-like motoric phenotype in 2C19TG transgenic mice is probably caused by changes in cerebellum, while hyperdopaminergism is most likely the compensatory adaptation, whereas the changes in the hippocampus, amygdala, septum, and nucleus accumbens may be connected with the mutants’ depression-like phenotype and susceptibility to stress. Therefore, CYP2C19 transgenic mouse in potentially useful model of hyperkinetic disorders, and our findings hint at the possible impact of CYP2C19 enzyme on the development of the several brain regions involved in motor and emotional functioning.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Preclinical, Journal:  Separate vmPFC ensembles control cocaine self-administration versus extinction in rats. (Pubmed Central) -  Jun 29, 2020   
    Our results demonstrate that neuronal ensembles mediating cocaine self-administration and extinction co-mingle in vmPFC and but have distinct outputs to the NAc core and shell that promote or inhibit cocaine seeking.SIGNIFICANCE STATEMENTNeuronal ensembles within the vmPFC have recently been shown to play a role in self-administration and extinction of food seeking. Here, we used the Daun02 chemogenetic inactivation procedure, which allows selective inhibition of neuronal ensembles identified by the activity marker Fos, to demonstrate that different ensembles for cocaine self-administration and extinction memories co-exist in the ventral mPFC and interact with distinct subregions of the nucleus accumbens.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  Ecopipam as a pharmacologic treatment of stuttering. (Pubmed Central) -  May 27, 2020   
    Here, we used the Daun02 chemogenetic inactivation procedure, which allows selective inhibition of neuronal ensembles identified by the activity marker Fos, to demonstrate that different ensembles for cocaine self-administration and extinction memories co-exist in the ventral mPFC and interact with distinct subregions of the nucleus accumbens. These positive, preliminary findings suggest that a doubleblind, randomized controlled clinical trial to examine the efficacy of ecopipam in the treatment of stuttering is warranted.
  • ||||||||||  aripiprazole / Generic mfg., risperidone / Generic mfg., Egis, olanzapine / Generic mfg.
    Review, Journal:  The Pharmacologic Treatment of Stuttering and Its Neuropharmacologic Basis. (Pubmed Central) -  Apr 16, 2020   
    In addition, VMAT-2 inhibitors alter dopamine transmission in a unique mechanism of action that offers a promising treatment avenue in stuttering. This review seeks to highlight the different treatment options to help guide the practicing clinician in the treatment of stuttering.
  • ||||||||||  olanzapine / Generic Mfg.
    The D1 Positive Allosteric Modulator, DETQ, Improves Cognition and Negative Symptoms in Subchronic Phencyclidine (PCP)-Treated and Aged Mice (Bonnet Creek IX) -  Oct 17, 2019 - Abstract #ACNP2019ACNP_884;    
    A subeffective dose (SED) of DETQ, 3mg/kg + SED olanzapine, 0.3 mg/kg, or SED rivastigmine, a cholinesterase inhibitor, also rescued NOR in sc-PCP mice, while the D2R antagonist, haloperidol.,0.3 mg/kg, and the GABAAR antagonist, gabazine, prevented rescue by DETQ...Unique Data The behavioral data in young and old mice are unique and are relevant to clinical use of DETQ for schizophrenia and aging. Ongoing behavioral and dialysis in studies in sc-PCP and aged mice treated with acute and sc-DETQ will further delineate the mechanisms by which DETQ improves memory and SI.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Treatment of dopaminergic augmented RLS with Ecopipam, A D1 specific antagonist: an exploratory placebo controlled cross-over trial (Les Muses Terrace, Level 3) -  Sep 24, 2019 - Abstract #MDSCongress2019MDS_524;    
    This study is designed to determine whether ecopipam is efficacious in the treatment of TS and to further characterize the safety profile of this drug in children and adolescent patients. Ecopipam was well tolerated and demonstrated encouraging preliminary efficacy results in augmented RLS patients.  Larger trials in augmented RLS, and potentially de novo RLS, are warranted.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial primary completion date:  Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years (clinicaltrials.gov) -  Apr 5, 2017   
    P2,  N=40, Active, not recruiting, 
    Not yet recruiting --> Active, not recruiting Trial primary completion date: Dec 2016 --> Dec 2019
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Enrollment closed, Enrollment change:  Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years (clinicaltrials.gov) -  Nov 3, 2016   
    P2,  N=40, Active, not recruiting, 
    Trial primary completion date: Dec 2016 --> Dec 2019 Recruiting --> Active, not recruiting | N=30 --> 40
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial primary completion date:  Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years (clinicaltrials.gov) -  Apr 15, 2016   
    P2,  N=30, Recruiting, 
    Not yet recruiting --> Recruiting Trial primary completion date: Dec 2015 --> Dec 2016
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial primary completion date:  Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years (clinicaltrials.gov) -  Apr 19, 2015   
    P2,  N=30, Recruiting, 
    Trial primary completion date: Dec 2015 --> Dec 2016 Trial primary completion date: Apr 2015 --> Dec 2015
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial termination:  Ecopipam Treatment of Tourette Syndrome (clinicaltrials.gov) -  Jul 19, 2012   
    P1/2,  N=18, Terminated, 
    Recruiting --> Completed Recruiting --> Terminated