ecopipam (PSYRX 101) / Paragon Biosci 
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  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial completion:  EBS-101-HV-106: Drug Interaction Study (clinicaltrials.gov) -  Aug 28, 2024   
    P1,  N=45, Completed, 
    Recruiting --> Completed
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Safety and Tolerability of Ecopipam in Tourette Syndrome (TS) with Psychiatric Comorbidities. (Poster Hall (Exhibit Hall A)) -  Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_831;    
    There is no evidence that ecopipam increases the risk of metabolic syndrome. In the phase IIb trial of children with TS, ecopipam significantly reduced the YGTSS-TTS while not affecting measures of common psychiatric comorbidities.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial completion:  Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years (clinicaltrials.gov) -  Apr 19, 2024   
    P2,  N=40, Completed, 
    This research has implications for understanding the effort-related motivational dysfunctions seen in psychopathology. Unknown status --> Completed
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Effects of Ecopipam on Growth and Development in Juvenile Rats (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_4117;    
    Ecopipam dose-related effects of decreased body weight gain and food consumption in juvenile rats were consistent with its primary pharmacology and demonstrated signs of recovery upon cessation of dosing. Ecopipam did not demonstrate adverse effects on maturation or growth and development.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Safety and Tolerability of Ecopipam in Tourette Syndrome with Psychiatric Comorbidities (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_4108;    
    Ecopipam did not demonstrate adverse effects on maturation or growth and development. In the D1AMOND trial of children and adolescents with TS, ecopipam significantly reduced the YGTSS-TTS while not affecting measures of common psychiatric comorbidities.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Enrollment open:  EBS-101-HV-106: Drug Interaction Study (clinicaltrials.gov) -  Feb 5, 2024   
    P1,  N=40, Recruiting, 
    In the D1AMOND trial of children and adolescents with TS, ecopipam significantly reduced the YGTSS-TTS while not affecting measures of common psychiatric comorbidities. Not yet recruiting --> Recruiting
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    New P1 trial:  EBS-101-HV-106: Drug Interaction Study (clinicaltrials.gov) -  Jan 8, 2024   
    P1,  N=40, Not yet recruiting, 
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Evolving Nonstandard Tic Treatment Approaches (Empire Ballroom East (Sheraton New York Times Square Hotel); In-person) -  Sep 30, 2023 - Abstract #AACAP2023AACAP_1006;    
    The D1 DA receptor antagonist SCH39166 (1 While we await results from the new, promising dopamine D1-blocking pharmacologic agent, ecopipam, our objective in this talk is to review the safety and efficacy of various nontraditional behavioral, medicinal, and neuromodulatory treatment options for Tourette
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  Acupuncture modulates development of myopia by reducing NLRP3 inflammasome activation via the dopamine-D1R signaling pathway. (Pubmed Central) -  May 22, 2023   
    A dopamine receptor 1 (D1R) inhibitor (SCH39166) was also administered to the hamsters...Furthermore, we also demonstrated that nucleotide-binding oligomerization domain (NOD)-, leucine-rich repeat (LRR)- and pyrin domain-containing protein 3 (NLR) family pyrin domain-containing 3 (NLRP3) inflammasome activation was inhibited by activation of the D1R signaling pathway. Our findings suggest that acupuncture inhibits myopia development by suppressing inflammation, which is initiated by activation of the dopamine-D1R signaling pathway.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Efficacy, Safety and Tolerability of Ecopipam in Tourette Syndrome With Psychiatric Comorbidities (Hall B Foyer, Exhibition Level Moscone South) -  May 17, 2023 - Abstract #APA2023APA_1134;    
    Although not powered for the subgroups, ecopipam shows strong trends for efficacy in patients with the comorbidities of ADHD, ANX, or OCD. There were no differences in efficacy, safety, or tolerability between those with and without these comorbid disorders.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci, gemlapodect (NOE-105) / Noema Pharma
    A Validated Rating Scale to Accurately Determine the Treatment Effects in Childhood Onset Fluency Disorder (Stuttering)--the MLGSS. (Salon 4) -  May 9, 2023 - Abstract #ASCP2023ASCP_410;    
    A commonly used scale in stuttering assessment, the OASES, (secondary endpoint in the Ecopipam trials) although subject rated, is not reliable to measure treatment effects over time given its lengthy nature (100 questions for the adult version--subject rater fatigue.) A more compact subjective measure, the SSS, also a secondary endpoint in the above trials, yielded more reliable results than the above scales but it too is limited by several factors including that the items are unstructured and not standardized as to the time (e.g. "today's session" vs. "last week.") To overcome our unmet medical need in developing viable treatments for our stuttering community, Maguire, Leal and Garibaldi created the MLGSS (Maguire, Garibaldi, Leal Stuttering Scale), a 10 item, subject rated assessment of their own stuttering and its impact over the prior week...A further validation study of the ability of the MLGSS to measure treatment effects over time is currently being conducted in the Orpheus study which is a trial of gemlapodenct (NOE-105), a PDE-10A inhibitor, in a double-blind placebo-controlled, multicenter Phase II trial for the treatment in COFD (stuttering.) Learning Objectives 1...2. Summarize the challenges in reliably assessing stuttering severity over time.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Design of a Phase 3 Maintenance-of-Effect Trial of Ecopipam in Tourette Syndrome (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_3967;    
    Simulations informed both enrollment and duration requirements. Conclusions This EERW design meets feasibility requirements, provides up to 24 weeks of safety data, and is powered to determine maintenance of efficacy of ecopipam for TS while reducing placebo exposure for this serious disorder.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Preclinical, Journal:  Ultra-high-field pharmacological functional MRI of dopamine D1 receptor-related interventions in anesthetized rats. (Pubmed Central) -  Feb 27, 2023   
    Regardless of the presence of isoflurane anesthesia, c-fos expression level was increased in the region where positive BOLD responses were observed with administration of SKF82958. These findings demonstrated that phfMRI could be used to identify the effects of direct D1 blockade on physiological brain functions and also for neurophysiological assessment of dopamine receptor functions in living animals.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Enrollment open:  D1AMOND: Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults (clinicaltrials.gov) -  Feb 3, 2023   
    P3,  N=196, Recruiting, 
    These findings demonstrated that phfMRI could be used to identify the effects of direct D1 blockade on physiological brain functions and also for neurophysiological assessment of dopamine receptor functions in living animals. Not yet recruiting --> Recruiting
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Clinical, Journal:  Ecopipam for Tourette Syndrome: A Randomized Trial. (Pubmed Central) -  Jan 12, 2023   
    Headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%) were the most common adverse events. Among children and adolescents with TS, ecopipam reduces tics to a greater extent than placebo, without observable evidence of common antipsychotic-associated side effects.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Pharmacological Interventions for the Treatment of Tourette’s Syndrome in Youth: A Systematic Review and Network Meta-Analysis (Grand Saguaro) -  Oct 31, 2022 - Abstract #ACNP2022ACNP_892;    
    Because there were no differences in efficacy between any pairs of antipsychotics based on the currently available data, the choice of antipsychotic should be guided mainly by their tolerability. Nevertheless, whether antipsychotics should be used as first-line pharmacological interventions in the treatments of TS is debatable given they are potentially toxic and may lead to somatic and serious adverse events, particularly in vulnerable populations such as children and adolescents.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  Effect of dopamine receptor-related compounds on naive common marmosets for auditory steady state response. (Pubmed Central) -  Jul 15, 2022   
    However, administration of a dopamine D1 receptor antagonist (SCH-39166, 0.3 mg/kg ip) resulted in a significant decrease in EP and PLF at 30 Hz...Subcutaneous administration of the serotonin dopamine antagonist, risperidone (0.3 mg/kg), tended to increase IP and decrease PLF, but not significantly...Subcutaneous administration of the serotonin dopamine antagonist, risperidone (0.3 mg/kg), tended to increase IP and decrease PLF, but not significantly. Taken together, it is possible to compare the differences in the mode of action of drugs on ASSR using naïve non-human primates.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Review, Journal:  Tourette Syndrome Treatment Updates: a Review and Discussion of the Current and Upcoming Literature. (Pubmed Central) -  Apr 14, 2022   
    There are several recent or ongoing pharmacologic studies that have shown promise including the selective D1 receptor antagonist ecopipam and various cannabinoid compounds...In recent years, there has been a wealth of research across multiple treatment domains in the TS field. This review highlights exciting and new potential options for the future treatment of patients with TS.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  D1/D5 dopamine receptors and mGluR5 jointly enable non-Hebbian long-term potentiation at sensory synapses onto lamina I spinoparabrachial neurons. (Pubmed Central) -  Feb 17, 2022   
    This non-Hebbian LTP was blocked by the D1/D5R antagonist SCH 39166 or genetic deletion of D5R, and required activation of mGluR5 and intracellular Ca release but was independent of NMDAR activation...Here we demonstrate that the activation of spinal D1/D5 dopamine receptors (D1/D5Rs) promotes a switch from Hebbian to non-Hebbian LTP, such that primary afferent stimulation alone is sufficient to evoke LTP in the absence of action potential discharge in projection neurons, which required joint activation of mGluR5 and intracellular Ca release but not NMDARs. These results suggest that D1/D5Rs cooperate with mGluR5 receptors in the spinal dorsal horn to powerfully influence the amplification of ascending nociceptive transmission to the brain.
  • ||||||||||  dextroamphetamine immediate release / Generic mfg.
    Preclinical, Journal:  Dopaminergic mechanisms underlying the expression of antipsychotic-induced dopamine supersensitivity in rats. (Pubmed Central) -  Feb 8, 2022   
    Finally, after discontinuing haloperidol treatment, neither increasing ventral midbrain dopamine impulse flow nor infusing d-amphetamine into the cerebral ventricles triggered the expression of already established antipsychotic-evoked dopamine supersensitivity, suggesting that peripheral effects are required. Thus, while dopamine receptor-mediated signalling regulates the expression of antipsychotic-evoked dopamine supersensitivity, a simple increase in central dopamine neurotransmission is insufficient to trigger this supersensitivity.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Enrollment closed:  Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely) (clinicaltrials.gov) -  Dec 16, 2021   
    P2,  N=68, Active, not recruiting, 
    We suggest that ID affects DA and ADE neuromodulation by way of A1R-D1R and possibly D1R-D3R heteromers. Recruiting --> Active, not recruiting
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Journal:  A novel Phosphodiesterase 1 inhibitor reverses L-Dopa-induced dyskinesia, but not motivation deficits, in monkeys. (Pubmed Central) -  Nov 24, 2021   
    A dopamine D receptor antagonist SCH-39166 at 0.01, 0.03 and 0.1 mg/kg potently decreased motivation in monkeys...Further, this compound decreased on-time with marked or severe dyskinesia, without affecting on-time itself. These findings suggest that PDE1 inhibitor could be a therapeutic candidate for treating L-dopa-induced dyskinesia in Parkinson's disease, but not for motivation deficits.
  • ||||||||||  Ingrezza (valbenazine) / Neurocrine, Mitsubishi Tanabe, Austedo (deutetrabenazine) / Teva, ecopipam (PSYRX 101) / Paragon Biosci
    Clinical, Journal:  Tourette syndrome in children: An update. (Pubmed Central) -  Nov 10, 2021   
    Pharmacotherapy is used if appropriate and several new medicines are under investigation (e.g., Tetrabenazine, valbenazine, deutetrabenazine, ecopipam, cannabinoids). Deep brain stimulation and Mouthguard therapy can be used for children with intractable illness.
  • ||||||||||  ecopipam (PSYRX 101) / Paragon Biosci
    Trial completion date, Trial primary completion date:  Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely) (clinicaltrials.gov) -  Nov 3, 2021   
    P2,  N=68, Recruiting, 
    Deep brain stimulation and Mouthguard therapy can be used for children with intractable illness. Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Sep 2021 --> Mar 2022