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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04171258
Other study ID # HG-BOTCD-PI-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 26, 2020
Est. completion date October 26, 2021

Study information

Verified date November 2021
Source Hugel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date October 26, 2021
Est. primary completion date April 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Hugel Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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.
severity (0~35 points)
pain (0~20 points)
disability( 0~30 points) Total score ranges from 0 to 85 points.
Baseline to Week 4 , Week 8, Week 12
See also
  Status Clinical Trial Phase
Completed NCT03617367 - Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) Phase 3
Not yet recruiting NCT04057911 - A Trial of Non-invasive Stimulation in Cervical Dystonia N/A
Withdrawn NCT02180139 - tDCS in Cervical Dystonia N/A
Completed NCT00541905 - Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia Phase 4
Unknown status NCT00418925 - Efficacy of Dronabinol for the Treatment of Cervical Dystonia Phase 2
Not yet recruiting NCT05715138 - Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia N/A
Completed NCT02131467 - Safety and Tolerability of Perampanel in Cervical Dystonia Phase 1/Phase 2
Completed NCT02959645 - Assessment of Brain Activities in Cervical Dystonia
Completed NCT03805152 - Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia Phase 3
Completed NCT04949594 - Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Recruiting NCT01664013 - The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients Phase 4
Completed NCT00447772 - Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia Phase 3
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT05157100 - Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia Phase 4
Completed NCT00257660 - Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia Phase 3
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
Completed NCT00323765 - Plasticity in Cervical Dystonia N/A
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2
Completed NCT03471923 - Non-Motor Features of Cervical Dystonia (CD)