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

Last updated: October 2, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Muscular Dystrophy

Myasthenia Gravis (Chronic Weakness)

Treatment

Leuprorelin Acetate

Clinical Study ID

NCT03555578
Leuprorelin-5004
JapicCTI-183981
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All SBMA patients who have been confirmed as receiving the drug

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 1890
Treatment Group(s): 1
Primary Treatment: Leuprorelin Acetate
Phase:
Study Start date:
November 02, 2017
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Takeda Selected Site

    Tokyo,
    Japan

    Site Not Available

  • Takeda Selected Site

    Tokyo 1850147,
    Japan

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.