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New treatment option for Spinal and Bulbar Muscular Atrophy
Official title A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy
ClinicalTrials.gov ID: NCT06169046
What this study is testing
What is Clenbuterol?
Clenbuterol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for spinal and bulbar muscular atrophy.
Also referred to as active.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- concomitant treatment with either beta-blockers or sympathomimetic drugs (If a beta-blockers concomitant medication is ongoing before the study...
- inability to walk or walking only with the support of a caregiver;
- use of beta2 agonists in the preceding 6 months;
- participation to an treatment trial in the preceding 3 months;
See the full eligibility criteria
- 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.
- 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...
- 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...
- inability to walk or walking only with the support of a caregiver;
- use of beta2 agonists in the preceding 6 months;
- participation to an treatment trial in the preceding 3 months;
- neuromuscular disease other than SBMA.
The study team makes the final eligibility decision.
Where it's taking place
- Padova, PD, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Padova, PD, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.