Spinal and Bulbar Muscular AtrophyNCT03555578
Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
An observational study of Spinal and Bulbar Muscular Atrophy, run by Takeda at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal and Bulbar Muscular Atrophy
- What is being tested?
- Leuprorelin Acetate
- Type of treatment
- Injection or infusion
- How many people
- 1,905 participants
- Where
- 1 siteJapan
- Study dates
- 2 Nov 2017to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: SBMA patients treated with Leuprorelin Acetate Injection Kit 11.25 mg as part of routine medical care
Who may be able to join
- All SBMA patients who have been confirmed as receiving the drug
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal and Bulbar Muscular Atrophy
- Being tested
- Leuprorelin Acetate
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprorelin AcetateDrug
Also called Leuplin SR for Injection Kit 11.25 mg
Leuprorelin Acetate Injection Kit
| Study group | Role | What they receive |
|---|---|---|
| Leuprorelin Acetate 11.25 mg | 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. Receives: Drug: Leuprorelin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 Year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At final assessment point (up to 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start2 Nov 2017
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal and Bulbar Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,905 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555578
- Sponsor's protocol ID
- Leuprorelin-5004
- Other IDs
- jRCT1080223924
- Status last verified
- May 2026
- First submitted
- 1 Jun 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
- ClinicalTrials.gov ID
- NCT03555578
- Acronym / sponsor ID
- Leuprorelin-5004
- Conditions
- Spinal and Bulbar Muscular Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,905 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprorelin Acetate 11.25 mg | – | Drug: Leuprorelin AcetateLeuprorelin 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SBMA patients treated with Leuprorelin Acetate Injection Kit 11.25 mg as part of routine medical care
Key inclusion criteria (1 listed)
- All SBMA patients who have been confirmed as receiving the drug
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprorelin AcetateAlso: Leuplin SR for Injection Kit 11.25 mgLeuprorelin Acetate Injection Kit | Drug | Leuprorelin Acetate 11.25 mg |
Primary outcome
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.
4 secondary outcomes
Percentage of Participants without Death Event
Time frame: At final assessment point (up to 8 years)
Percentage of Participants without Pneumonia Requiring Hospitalization Event
Time frame: At final assessment point (up to 8 years)
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 Dysphagia Events
Time frame: At final assessment point (up to 8 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal and Bulbar Muscular Atrophy, run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who had One or More Adverse Drug Reactions (time frame: Up to 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.