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

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

1. Male or female of aged over 19 years
2. Subjects diagnosed with primary cervical dystonia

Exclusion criteria

1. Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
2. Pregnant or nursing
3. 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

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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]