Cervical Dystonia Clinical Trial
Official title:
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
Verified date | November 2021 |
Source | Hugel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hugel | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hugel |
Korea, Republic of,
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 |
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