An observational study in Spinal and Bulbar Muscular Atrophy, sponsored by Takeda. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Takeda · Observational
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.
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.
33 studies on the registry are indexed under Bulbo-Spinal Atrophy, X-Linked; 11 are open to participants now.
This study's enrollment of 1,905 is above the median of 675 across 10 observational studies indexed under Bulbo-Spinal Atrophy, X-Linked.
Browse Bulbo-Spinal Atrophy, X-Linked studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
SBMA patients treated with Leuprorelin Acetate Injection Kit 11.25 mg as part of routine medical care
Exclusion Criteria:
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.
Drug: Leuprorelin Acetate
Leuprorelin Acetate Injection Kit
Also known as: Leuplin SR for Injection Kit 11.25 mg
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.
Time frame: Up to 1 Year
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.
Time frame: Up to 1 Year
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.
Time frame: At final assessment point (up to 8 years)
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.
Time frame: At final assessment point (up to 8 years)
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.
Time frame: At final assessment point (up to 8 years)
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.
Time frame: At final assessment point (up to 8 years)
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Bulbo-Spinal Atrophy, X-Linked→
Takeda