NCT04171258

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2021

Completed
Last Updated

April 22, 2022

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

June 20, 2019

Last Update Submit

April 14, 2022

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (2)

  • rate of adverse event

    To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.

    12 weeks (during the clinical trial)

  • Change From Baseline in the Total Score of the TWSTRS score.

    The average of the change from baseline in TWSTRS-total score at Weeks 4, 8 and 12 will be determined. full name of TWSTRS is Toronto Western Spasmodic Torticollis Rating Scale. The validated assessment scale TWSTRS is consists of 3 sub-scales. 1. severity (0\~35 points) 2. pain (0\~20 points) 3. disability( 0\~30 points) Total score ranges from 0 to 85 points.

    Baseline to Week 4 , Week 8, Week 12

Study Arms (2)

Botulax®

EXPERIMENTAL
Drug: Botulinum toxin type A injection

Botox®

ACTIVE COMPARATOR
Drug: Botulinum Toxin Type A Injection [Botox]

Interventions

Botulinum toxin type A injectionDRUG

Experimental

Also known as: Botulax®
Botulax®
Botulinum Toxin Type A Injection [Botox]DRUG

Active Comparator

Also known as: Botox®
Botox®

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugel

Seoul, South Korea

Location

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

November 20, 2019

Study Start

May 26, 2020

Primary Completion

April 26, 2021

Study Completion

October 26, 2021

Last Updated

April 22, 2022

Record last verified: 2021-11

Locations

KR(1)