gemlapodect (NOE-105) / Noema Pharma 
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 1 Disease   3 Trials   3 Trials   14 News 
  • ||||||||||  gemlapodect (NOE-105) / Noema Pharma
    Enrollment closed, Trial primary completion date:  A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus) (clinicaltrials.gov) -  Aug 14, 2023   
    P2b,  N=67, Active, not recruiting, 
    Phase classification: P2b --> P2 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2023 --> Oct 2023
  • ||||||||||  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.
  • ||||||||||  RG7203 / Roche
    Clinical, Journal:  Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients With Negative Symptoms. (Pubmed Central) -  Nov 18, 2020   
    P1
    Data were analyzed in a randomized, three-way cross-over, proof-of-mechanism study (ClinicalTrials.gov: NCT02824055) comparing two doses of RG7203 with placebo, given as adjunct to stable antipsychotic treatment in patients with chronic schizophrenia and moderate levels of negative symptoms...Activity measures showed similar correlations with PANSS negative symptom factor but did not reach significance. Our findings support the use of wrist-worn devices to derive activity and gesture-based digital outcome measures for patients with schizophrenia with negative symptoms in a clinical trial setting.