Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia

H

Hugel

Status and phase

Completed
Phase 1

Conditions

Cervical Dystonia

Treatments

Drug: Botulinum toxin type A injection
Drug: Botulinum Toxin Type A Injection [Botox]

Study type

Interventional

Funder types

Industry

Identifiers

NCT04171258
HG-BOTCD-PI-01

Details and patient eligibility

About

To determine the efficacy and safety of Botulax® in treatment of cervical dystonia

Enrollment

38 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female of aged over 19 years
  • Subjects diagnosed with primary cervical dystonia

Exclusion criteria

  • Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
  • Pregnant or nursing
  • Females or males who do not agree on proper contraceptive measure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

Botulax®
Experimental group
Treatment:
Drug: Botulinum toxin type A injection
Botox®
Active Comparator group
Treatment:
Drug: Botulinum Toxin Type A Injection [Botox]

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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