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NCT04171258
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
Phase 1 trial testing Botulinum toxin type A injection in Cervical Dystonia in 38 participants. Completed in 26 October 2021.
26 April 2021
Quick facts
| Lead sponsor | Hugel |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 26 May 2020 |
| Primary completion | 26 April 2021 |
| Estimated completion | 26 October 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Botulinum toxin type A injection — full drug profile →
- Botulinum Toxin Type A Injection [Botox] — full drug profile →
Conditions studied
- Cervical Dystonia — all drugs for Cervical Dystonia →
Sponsor
Hugel — full company profile →
Who can join
19 and older, any sex, with Cervical Dystonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Treatment of Dystonia: Medications, Neurotoxins, Neuromodulation, and Rehabilitation.
Bledsoe IO, Viser AC, San Luciano M. · · 2020 · cited 34× · PMID 33095402 · DOI 10.1007/s13311-020-00944-0
Verify or expand the search:
- PubMed search for NCT04171258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Botulinum toxin type A injection
Trials testing the same drug.
- NCT06886750 — The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia · Phase 4 · not yet recruiting
- NCT06094309 — Effectiveness of Botulinum Toxin in Freezing of Gate in Parkinson's Disease Walking in Parkinson's Disease. · NA · unknown
- NCT05651256 — Efficacy of Botulinum Toxin in Temporomandibular Disorders · Phase 2, PHASE3 · completed
- NCT04186442 — Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder · Phase 1 · completed
- NCT04207632 — Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study · unknown
Other recruiting trials for Cervical Dystonia
Currently open trials in the same condition.
- NCT07140874 — Zinc as an Adjunctive Therapy for Cervical Dystonia · Phase 2 · recruiting
- NCT06937931 — A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults · Phase 2 · recruiting
Other Hugel trials
Trials by the same sponsor.
- NCT06216418 — Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds · NA · unknown
- NCT04944953 — To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines. · Phase 1 · completed
- NCT04443244 — Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy · Phase 2 · completed
- NCT04186442 — Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder · Phase 1 · completed
- NCT04012099 — the Hypertrophic Scar Prevention of BMT101. · Phase 2 · terminated
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 NCT04171258 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Hugel
- Last refreshed: 22 April 2022
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/NCT04171258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing