EICHORCondition: Spinal and Bulbar Muscular Atrophy · Sponsor: Gianni Soraru
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There is no cure to arrest or delay SBMA progression. It is estimated that \~1000 individuals are affected by SBMA in Italy at any given time (prevalence: 1.5/100000) with an annual incidence of 0.19/100000 males. Here, we are going to test the potential of beta2-agonist stimulation on muscle as a therapeutic avenue for SBMA. We have provided pre-clinical evidence that β-agonist stimulation may be a therapeutic strategy for SBMA. Moreover, we have shown that beta2-agonists are effective in improving motor function without relevant adverse events in a small cohort of SBMA patients. To establish safety and efficacy of clenbuterol as a cure for SBMA, we are conducting a multicenter, phase II, randomized, double-blind, parallel-group, single dose, placebo-controlled trial. Indeed, based on our preliminary data, some concerns remain to be addressed.
This description comes directly from the study's public registry record.
Gianni Sorarù, MD · 0498213600 · gianni.soraru@unipd.it
Elisabetta Pupillo, PharmD · 0239014605 · elisabetta.pupillo@marionegri.it
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| Azienda Ospedale Università di Padova | Padova, PD, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06169046