Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg “All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)”

study id #: NCT03555578

condition: Spinal and Bulbar Muscular Atrophy

status: Recruiting

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.

intervention: Leuprorelin Acetate

results: https://clinicaltrials.gov/ct2/show/results/NCT03555578

last updated: February 04, 2022

start date: November 2, 2017

estimated completion: August 31, 2025

last updated: December 23, 2020

size / enrollment: 300

study 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.

primary outcomes:

• 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
  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 outcomes:

• Percentage of Participants without Death Event
  At final assessment point (up to 8 years)
• Percentage of Participants without Pneumonia Requiring Hospitalization Event
  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)
• Percentage of Participants without Dysphagia Events
  At final assessment point (up to 8 years)

inclusion criteria:

exclusion criteria: Criteria:

None

sponsor: Takeda

contacts: Takeda Study Registration Call Center, +1-877-825-3327, medicalinformation@tpna.com

investigators: Study Director,Takeda

trial center locations: Japan

• Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg “All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)”