A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy
Recruiting
Phase 2
Interventional Study
Spinal and Bulbar Muscular Atrophy
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Gianni Soraru · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. males who have received a genetically confirmed diagnosis of SBMA (AR CAG repeat number \>= 38);
2. aged between 18 and 75 (+364 days) years;
3. displaying one or more of the following clinical symptoms: muscle atrophy, limb weakness, bulbar palsy;
4. able to walk independent…
Contacts