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NCT03543150
BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
trial testing BOTOX in Dysphonia in 400 participants. Status unknown.
28 February 2022
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 20 July 2018 |
| Primary completion | 28 February 2022 |
| Estimated completion | 28 February 2022 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- BOTOX (ONABOTULINUMTOXINA) — full drug profile →
Conditions studied
- Dysphonia — all drugs for Dysphonia →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Eligibility, any sex, with Dysphonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study.
Iimura S, Nose Y, Tabata K, Oda K, et al · · 2023 · cited 1× · PMID 37755979 · DOI 10.3390/toxins15090553
Verify or expand the search:
- PubMed search for NCT03543150
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06218251 — A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections · Phase 4 · completed
- NCT05956509 — Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participa · Phase 1 · terminated
- NCT06174688 — A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of Moderate to Severe Foreh · Phase 3 · completed
Other recruiting trials for Dysphonia
Currently open trials in the same condition.
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- NCT06779799 — Characterization of "Bamboo" and Other Vocal Cord Lesions Responsible for Dysphonia in Patients With Systemic Autoimmune · recruiting
- NCT07145086 — Translaryngeal Vibration for Hyperfunctional Voice Disorders · Phase 3 · recruiting
- NCT05317390 — Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia · NA · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03543150 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 7 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03543150.
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