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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT03555578 |
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Date of registration:
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01/06/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
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Scientific title:
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Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)" |
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Date of first enrolment:
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November 2, 2017 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03555578 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Takeda Study Registration Call Center |
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Address:
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Telephone:
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+1-877-825-3327 |
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Email:
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medicalinformation@tpna.com |
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Affiliation:
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All SBMA patients who have been confirmed as receiving the drug
Exclusion Criteria:
- None
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal and Bulbar Muscular Atrophy
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Intervention(s)
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Drug: Leuprorelin Acetate
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Primary Outcome(s)
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Percentage of Participants who had One or More Serious Adverse Events
[Time Frame: Up to 1 Year]
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Percentage of Participants who had One or More Adverse Drug Reactions
[Time Frame: Up to 1 Year]
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Secondary Outcome(s)
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Percentage of Participants without Death Event
[Time Frame: At final assessment point (up to 8 years)]
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Percentage of Participants without Pneumonia Requiring Hospitalization Event
[Time Frame: At final assessment point (up to 8 years)]
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Percentage of Participants without Dysphagia Events
[Time Frame: At final assessment point (up to 8 years)]
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Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization
[Time Frame: At final assessment point (up to 8 years)]
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Secondary ID(s)
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JapicCTI-183981
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Leuprorelin-5004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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