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Completed

NCT Number: NCT03555578

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

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.

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Key information

Conditions

Spinal and Bulbar Muscular Atrophy Bulbo-Spinal Atrophy, X-Linked Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Leuprorelin Acetate

Drug

Leuprorelin Acetate Injection Kit

Other names: Leuplin SR for Injection Kit 11.25 mg

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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