Status:
RECRUITING
A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy
Lead Sponsor:
Gianni Soraru
Collaborating Sponsors:
Mario Negri Institute for Pharmacological Research
Conditions:
Spinal and Bulbar Muscular Atrophy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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/...
Eligibility Criteria
Inclusion
- males who have received a genetically confirmed diagnosis of SBMA (AR CAG repeat number \>= 38);
- aged between 18 and 75 (+364 days) years;
- displaying one or more of the following clinical symptoms: muscle atrophy, limb weakness, bulbar palsy;
- able to walk independently with or without a cane or other supporting device (all supporting devices are acceptable except on wheelchair);
- providing a written informed consent.
Exclusion
- a documented cardiovascular disease precluding the use of beta2 agonists (in the judgment of the investigators);
- glaucoma, severe prostatic hypertrophy, hyperthyroidism, pheochromocytoma, and other medical conditions that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study;
- concomitant treatment with either beta-blockers or sympathomimetic drugs (If a beta-blockers concomitant medication is ongoing before the study inclusion, the patient can be enrolled if the beta-blocker is discontinued for 3 weeks prior to randomization visit);
- inability to walk or walking only with the support of a caregiver;
- use of beta2 agonists in the preceding 6 months;
- participation to an interventional trial in the preceding 3 months;
- neuromuscular disease other than SBMA.
Key Trial Info
Start Date :
April 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06169046
Start Date
April 13 2024
End Date
December 31 2027
Last Update
April 15 2024
Active Locations (1)
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1
Azienda Ospedale Università di Padova
Padua, PD, Italy, 35134