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)"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03555578
• Other study ID #: Leuprorelin-5004
• Secondary ID: JapicCTI-183981
• Status: Recruiting
• Start date: November 2, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: Takeda Study Registration Call Center
• Phone: +1-877-825-3327
• Email: medicalinformation[@]tpna.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

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

Intervention

Drug:
• Leuprorelin Acetate
Leuprorelin Acetate Injection Kit

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who had One or More Adverse Drug Reactions	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.	Up to 1 Year
Primary	Percentage of Participants who had One or More Serious Adverse Events	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.	Up to 1 Year
Secondary	Percentage of Participants without Death Event	Percentage of participants without events of death at final assessment point (up to 8 years from initiation of treatment) will be reported.	At final assessment point (up to 8 years)
Secondary	Percentage of Participants without Pneumonia Requiring Hospitalization Event	Percentage of participants without events of pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported.	At final assessment point (up to 8 years)
Secondary	Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization	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.	At final assessment point (up to 8 years)
Secondary	Percentage of Participants without Dysphagia Events	Percentage of participants without events of dysphagia at final assessment point (up to 8 years from initiation of treatment) will be reported.	At final assessment point (up to 8 years)