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

Recruiting

• Conditions: Spinal and Bulbar Muscular Atrophy
• Interventions: Drug: Leuprorelin Acetate

• Registration Number: NCT03555578
• Lead Sponsor: Takeda

Brief 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.

Study Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Leuprorelin Acetate 11.25 mg	Leuprorelin Acetate	Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who had One or More Serious Adverse Events	Up to 1 Year	Percentage of participants who have the serious adverse events that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported.
Percentage of Participants who had One or More Adverse Drug Reactions	Up to 1 Year	Adverse drug reaction refers to adverse events related to administered drug. Percentage of participants who have the adverse drug reactions that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants without Death Event	At final assessment point (up to 8 years)	Percentage of participants without events of death at final assessment point (up to 8 years from initiation of treatment) will be reported.
Percentage of Participants without Pneumonia Requiring Hospitalization Event	At final assessment point (up to 8 years)	Percentage of participants without events of pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported.
Percentage of Participants without Dysphagia Events	At final assessment point (up to 8 years)	Percentage of participants without events of dysphagia at final assessment point (up to 8 years from initiation of treatment) will be reported.
Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization	At final assessment point (up to 8 years)	Percentage of participants without composite events of death and pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan