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)"
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.
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Takeda Selected Site | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Japan,
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) |
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