Testing clenbuterol for treating spinal and bulbar muscular atrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of clenbuterol, a beta2-agonist, in patients diagnosed with spinal and bulbar muscular atrophy (SBMA). The study is a multicenter, phase II, randomized, double-blind, placebo-controlled trial involving male participants aged 18 to 75 who exhibit symptoms of muscle atrophy or weakness. The trial will assess the potential of clenbuterol to improve motor function and address concerns raised in preliminary studies. Participants will receive either clenbuterol or a placebo in a controlled setting to determine the treatment's effectiveness.

Why it matters

Who can join: the full rules

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 independently with or without a cane or other supporting device (all supporting devices are acceptable except on wheelchair);
5. providing a written informed consent.

Exclusion Criteria:

1. a documented cardiovascular disease precluding the use of beta2 agonists (in the judgment of the investigators);
2. 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;
3. 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);
4. inability to walk or walking only with the support of a caregiver;
5. use of beta2 agonists in the preceding 6 months;
6. participation to an interventional trial in the preceding 3 months;
7. neuromuscular disease other than SBMA.

Where it's running

• Azienda Ospedale Università di Padova
  Padova, Pd, Italy Recruiting

Study contacts

• Principal investigator: Gianni Sorarù, MD — Azienda Ospedale Università di Padova
• Study coordinator: Gianni Sorarù, MD
• Email: gianni.soraru@unipd.it
• Phone: 0498213600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.