DystoniaPhase 3NCT03232320
Meditoxin® Treatment in Patients With Cervical Dystonia
A Phase 3 study testing Meditoxin in people with Dystonia and Dystonic Disorder, run by Medy-Tox at 1 site in South Korea.
Trial summary
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline) Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dystonia, Dystonic Disorder
- What is being tested?
- Meditoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2017to 5 Nov 2018
- 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
- Male or female aged 20 to less than 75 years
- Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10
Who cannot join
- Subjects with pure anterocollis
- Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
- A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
- Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
- Conditions
- Dystonia, Dystonic Disorder
- Being tested
- Meditoxin, Placebo
- Medical subject headings
- Dystonia, Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditoxinDrug
Meditoxin (Botulinum toxin type A)
PlaceboDrug
Placebo (Normal saline)
| Study group | Role | What they receive |
|---|---|---|
| MEDITOXIN | Experimental | Not described Receives: Drug: Meditoxin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Measured: week 4 follow-up visit
Secondary outcomes (3)
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline
Measured: week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline
Measured: week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline
Measured: week 4 follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start6 Jul 2017
- Primary completion31 Oct 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 66 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
- NCT03232320
- Sponsor's protocol ID
- MT01-KR16CVD309
- Status last verified
- Mar 2019
- First submitted
- 25 Jul 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 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, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT03232320
- Acronym / sponsor ID
- MT01-KR16CVD309
- Conditions
- Dystonia, Dystonic Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 27 Jul 2017 (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 Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
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 | Drug: Meditoxin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 20 to less than 75 years
- Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10
Key exclusion criteria (4 listed)
- Subjects with pure anterocollis
- Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
- A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
- Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study
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 |
|---|---|---|
| MeditoxinMeditoxin (Botulinum toxin type A) | Drug | MEDITOXIN |
| PlaceboPlacebo (Normal saline) | Drug | Placebo |
Primary outcome
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Time frame: week 4 follow-up visit
3 secondary outcomes
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline
Time frame: week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline
Time frame: week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline
Time frame: week 4 follow-up visit
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 27 Mar 2019.
Related trials for Dystonia
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Recruiting
Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Limb Dystonia, Idiopathic Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
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 3 study testing Meditoxin in people with Dystonia and Dystonic Disorder, run by Medy-Tox 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 4 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 27 Mar 2019. 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. Some participants in this study may receive a placebo. 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 Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline (time frame: week 4 follow-up visit). 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 27 Mar 2019.