Cervical DystoniaPhase 1NCT04171258
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
A Phase 1 study testing Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox] in people with Cervical Dystonia, run by Hugel at 1 site in South Korea.
Trial summary
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2020to 26 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of aged over 19 years
- Subjects diagnosed with primary cervical dystonia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
- Conditions
- Cervical Dystonia
- Being tested
- Botulinum toxin type A injection, Botulinum Toxin Type A Injection [Botox]
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
Also called Botulax®
Experimental
Botulinum Toxin Type A Injection [Botox]Drug
Also called Botox®
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Botulax® | Experimental | Not described Receives: Drug: Botulinum toxin type A injection |
| Botox® | Active comparator | Not described Receives: Drug: Botulinum Toxin Type A Injection [Botox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of adverse event
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.
Measured: 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.
- severity (0~35 points)
- pain (0~20 points)
- disability( 0~30 points) Total score ranges from 0 to 85 points.
Measured: Baseline to Week 4 , Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start26 May 2020
- Primary completion26 Apr 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171258
- Sponsor's protocol ID
- HG-BOTCD-PI-01
- Status last verified
- Nov 2021
- First submitted
- 20 Jun 2019
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04171258
- Acronym / sponsor ID
- HG-BOTCD-PI-01
- Conditions
- Cervical Dystonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 26 May 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulax® | Experimental | Drug: Botulinum toxin type A injection |
| Botox® | Active comparator | Drug: Botulinum Toxin Type A Injection [Botox] |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female of aged over 19 years
- Subjects diagnosed with primary cervical dystonia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A injectionAlso: Botulax®Experimental | Drug | Botulax® |
| Botulinum Toxin Type A Injection [Botox]Also: Botox®Active Comparator | Drug | Botox® |
Primary outcome
rate of adverse event
Time frame: 12 weeks (during the clinical trial)
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.
Change From Baseline in the Total Score of the TWSTRS score.
Time frame: Baseline to Week 4 , Week 8, Week 12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
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An Observational Study of Individuals With Isolated Dystonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox] in people with Cervical Dystonia, run by Hugel at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of adverse event (time frame: 12 weeks (during the clinical trial)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.