Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03555578
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date June 1, 2018
First Posted Date June 13, 2018
Last Update Posted Date January 14, 2022
Actual Study Start Date November 2, 2017
Estimated Primary Completion Date August 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2018)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 1, 2018)
  • Percentage of Participants without Death Event [ Time Frame: At final assessment point (up to 8 years) ]
    Percentage of participants without events of death at final assessment point (up to 8 years from initiation of treatment) will be reported.
  • Percentage of Participants without Pneumonia Requiring Hospitalization Event [ Time Frame: At final assessment point (up to 8 years) ]
    Percentage of participants without events of pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported.
  • 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 composite events of death and pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported.
  • Percentage of Participants without Dysphagia Events [ Time Frame: At final assessment point (up to 8 years) ]
    Percentage of participants without events of dysphagia at final assessment point (up to 8 years from initiation of treatment) will be reported.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
Official Title Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population SBMA patients treated with Leuprorelin Acetate Injection Kit 11.25 mg as part of routine medical care
Condition Spinal and Bulbar Muscular Atrophy
Intervention Drug: Leuprorelin Acetate
Leuprorelin Acetate Injection Kit
Other Name: Leuplin SR for Injection Kit 11.25 mg
Study Groups/Cohorts 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.
Intervention: Drug: Leuprorelin Acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 1, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2025
Estimated Primary Completion Date August 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All SBMA patients who have been confirmed as receiving the drug

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03555578
Other Study ID Numbers Leuprorelin-5004
JapicCTI-183981 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date January 2022