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

Spinal and Bulbar Muscular Atrophy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrophy
• Bulbo-Spinal Atrophy, X-Linked
• Muscular Atrophy
• Spinal and Bulbar Muscular Atrophy

• NCT number: NCT03555578
• Study type: Observational
• Source: Takeda
• Contact: Takeda Study Registration Call Center
• Phone: +1-877-825-3327
• Email: medicalinformation@tpna.com
• Status: Recruiting
• Start date: November 2, 2017
• Completion date: August 31, 2025