Survey on the use of leuprorelin acetate for spinal and bulbar muscular atrophy
Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
This study is trying to see how well and safely leuprorelin acetate works for people with spinal and bulbar muscular atrophy over a long period of time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1890 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT03555578 on ClinicalTrials.gov |
What this trial studies
This survey evaluates the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients diagnosed with spinal and bulbar muscular atrophy (SBMA). It is an observational study that will gather data from approximately 300 patients in a routine clinical setting across multiple centers in Japan. The study aims to provide insights into how this treatment performs over time without altering the standard care practices for these patients.
Who should consider this trial
Good fit: Ideal candidates for this survey are patients diagnosed with spinal and bulbar muscular atrophy who are already receiving leuprorelin acetate.
Not a fit: Patients who are not diagnosed with spinal and bulbar muscular atrophy or those not receiving leuprorelin acetate will not benefit from this survey.
Why it matters
Potential benefit: If successful, this survey could provide valuable information on the long-term effects of leuprorelin acetate, potentially improving treatment strategies for SBMA patients.
How similar studies have performed: While this approach is observational, similar studies evaluating long-term drug efficacy in rare conditions have shown promise in providing critical data for treatment optimization.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All SBMA patients who have been confirmed as receiving the drug Exclusion Criteria: * None
Where this trial is running
Tokyo
- Takeda Selected Site — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Study Registration Call Center
- Email: medicalinformation@tpna.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.