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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03555578
Other study ID # Leuprorelin-5004
Secondary ID JapicCTI-183981
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2017
Est. completion date August 31, 2025

Study information

Verified date February 2024
Source Takeda
Contact Takeda Study Registration Call Center
Phone +1-877-825-3327
Email medicalinformation@tpna.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All SBMA patients who have been confirmed as receiving the drug Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Leuprorelin Acetate
Leuprorelin Acetate Injection Kit

Locations

Country Name City State
Japan Takeda Selected Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. At final assessment point (up to 8 years)
Secondary 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. At final assessment point (up to 8 years)
Secondary 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. At final assessment point (up to 8 years)
Secondary 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. At final assessment point (up to 8 years)
See also
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Recruiting NCT06169046 - A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy Phase 2