Cervical DystoniaPhase 3CD Phase IIINCT03905304
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
A Phase 3 study testing Medytoxin and Botox in people with Cervical Dystonia, run by Medy-Tox.
Trial summary
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Medytoxin and Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2013to 5 Aug 2014
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 20 and 75.
- Patient who is diagnosed with primary cervical dystonia over 1 year.
- Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
- For patients with prior treatments of Botox®, over 12 weeks have passed.
- Patients who voluntarily sign the informed consent
- Patients who can comply with the study procedures and visit schedule
Who cannot join
- Patient who has been diagnosed with pure anterocollis.
- Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\
- Severe respiratory function disorder or dysphasia
- Allergy in Investigational Product.
- Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
- Investigator's decision.
About this study
Official title: A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.
Read the detailed description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.
- Conditions
- Cervical Dystonia
- Being tested
- Medytoxin, Botox
- Keywords
- CD phase III
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedytoxinBiological
Also called botulinum type A toxin
Intramuscular injection up to 300U.
BotoxBiological
Also called botulinum type A toxin
Intramuscular injection up to 300U.
| Study group | Role | What they receive |
|---|---|---|
| Meditoxin | Experimental | Meditoxin administered 200U~300U, single-dose administration. Receives: Biological: Medytoxin |
| Botox | Active comparator | Botox administered 200-300U, single-dose administration. Receives: Biological: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TWSTRS score
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
Measured: 1 month
Secondary outcomes (2)
Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
Number of adverse events occuring during the clinical trial.
Measured: 1, 2, 3 months
Change in TWSTRS score
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
Measured: 1, 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start9 Jan 2013
- Primary completion30 Jul 2014
- Study completion5 Aug 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905304
- Sponsor's protocol ID
- MT_PRT_CD01
- Acronym
- CD Phase III
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2019
- Last updated
- 8 Apr 2019
- 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 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT03905304
- Acronym / sponsor ID
- CD Phase III / MT_PRT_CD01
- Conditions
- Cervical Dystonia
- Keywords
- CD phase III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2013 (actual)
- Primary completion
- 30 Jul 2014 (actual)
- Study completion
- 5 Aug 2014 (actual)
- First posted
- 5 Apr 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.
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.
Detailed description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditoxin | Experimental | Biological: MedytoxinMeditoxin administered 200U~300U, single-dose administration. |
| Botox | Active comparator | Biological: BotoxBotox administered 200-300U, single-dose administration. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged between 20 and 75.
- Patient who is diagnosed with primary cervical dystonia over 1 year.
- Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
- For patients with prior treatments of Botox®, over 12 weeks have passed.
- Patients who voluntarily sign the informed consent
Key exclusion criteria (6 listed)
- Patient who has been diagnosed with pure anterocollis.
- Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\
- Severe respiratory function disorder or dysphasia
- Allergy in Investigational Product.
- Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
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 |
|---|---|---|
| MedytoxinAlso: botulinum type A toxinIntramuscular injection up to 300U. | Biological | Meditoxin |
| BotoxAlso: botulinum type A toxinIntramuscular injection up to 300U. | Biological | Botox |
Primary outcome
Change in TWSTRS score
Time frame: 1 month
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
2 secondary outcomes
Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
Time frame: 1, 2, 3 months
Change in TWSTRS score
Time frame: 1, 2, 3 months
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 8 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medytoxin and Botox in people with Cervical Dystonia, run by Medy-Tox.
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 6 inclusion and 6 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in TWSTRS score (time frame: 1 month). 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 8 Apr 2019.