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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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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

Study Description
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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.

Condition or disease Intervention/treatment
Spinal and Bulbar Muscular Atrophy Drug: Leuprorelin Acetate

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Leuprorelin Acetate
Leuprorelin Acetate Injection Kit
Other Name: Leuplin SR for Injection Kit 11.25 mg


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
SBMA patients treated with Leuprorelin Acetate Injection Kit 11.25 mg as part of routine medical care
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555578


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

Locations
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Japan
Takeda Selected Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03555578    
Other Study ID Numbers: Leuprorelin-5004
JapicCTI-183981 ( Registry Identifier: JapicCTI )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Atrophy
Bulbo-Spinal Atrophy, X-Linked
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Muscular Atrophy, Spinal
Spinal Cord Diseases
Central Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
 Motor Neuron Disease
Neuromuscular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents