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BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

NCT03543150 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-10-07

No results posted yet for this study

Summary

This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.

Conditions

  • Dysphonia

Interventions

DRUG

BOTOX

BOTOX injections will be administered to eligible subjects with diagnosis of spasmodic dysphonia. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-20
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543150 on ClinicalTrials.gov