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RECRUITING
NCT06169046
PHASE2

A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy

Sponsor: Gianni Soraru

View on ClinicalTrials.gov

Summary

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.

Official title: A Placebo-controlled Study to Evaluate the Efficacy and Safety of Clenbuterol in Patients With Spinal and Bulbar Muscular Atrophy (SBMA)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-04-13

Completion Date

2027-12-31

Last Updated

2024-04-15

Healthy Volunteers

No

Interventions

DRUG

Clenbuterol

tablets

DRUG

Placebo

tablets

Locations (1)

Azienda Ospedale Università di Padova

Padova, PD, Italy