DRUG
Leuprorelin Acetate
Leuprorelin Acetate Injection Kit
Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
Status
Completed
Phase
Not applicable
Enrollment
1,905
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 13, 2018
Study start
Nov 2, 2017
Primary completion
Apr 30, 2026
Study completion
Apr 30, 2026
Results posted
Not reported
Registry updated
May 22, 2026
Outcomes
What the study measures.
Primary outcomes
Percentage of Participants who had One or More Adverse Drug Reactions
Time frame · 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.
Percentage of Participants who had One or More Serious Adverse Events
Time frame · 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.
Secondary outcomes
Percentage of Participants without Death Event
Time frame · 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
Time frame · 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 Composite Events of Death and Pneumonia Requiring Hospitalization
Time frame · 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.
Percentage of Participants without Dysphagia Events
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * All SBMA patients who have been confirmed as receiving the drug Exclusion Criteria: * None
Study locations
1 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
Takeda Selected Site
Tokyo, Japan
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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