NCT03555578

Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,890 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.

Detailed description

The drug being tested in this survey is called leuprorelin acetate injection kit 11.25 mg. This injection kit is being tested to treat people who have SBMA. This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be approximately 300. This multi-center observational trial will be conducted in Japan.

Conditions

• Spinal and Bulbar Muscular Atrophy

Interventions

Type	Name	Description
DRUG	Leuprorelin Acetate	Leuprorelin Acetate Injection Kit

Timeline

• Start date: 2017-11-02
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2018-06-13
• Last updated: 2025-10-07

Locations

1 site across 1 country: Japan