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

NCT ID: NCT04171258

Last Updated: 2022-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2021-10-26

Brief Summary

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

Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botulax®

Group Type EXPERIMENTAL

Botulinum toxin type A injection

Intervention Type DRUG

Experimental

Botox®

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A Injection [Botox]

Intervention Type DRUG

Active Comparator

Interventions

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Botulinum toxin type A injection

Experimental

Intervention Type DRUG

Botulinum Toxin Type A Injection [Botox]

Active Comparator

Intervention Type DRUG

Other Intervention Names

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Botulax® Botox®

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hugel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hugel

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HG-BOTCD-PI-01

Identifier Type: -

Identifier Source: org_study_id

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