Adult Cerebral PalsyPhase 4ATHETOID_CDNCT01860196
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
A Phase 4 study testing Meditoxin and Normal saline in people with Adult Cerebral Palsy, run by Seoul National University Hospital.
Trial summary
This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adult Cerebral Palsy
- What is being tested?
- Meditoxin and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult cerebral palsy patients over 20 years old
- Clinically diagnosed for cervical dystonia more than a year ago
- No improvement with antispasmodics for the last month
- Actively participated and gave informed consent
Who cannot join
- Allergic to the botulinum toxin
- Limited range of motion in cervical spine
- Patients with fever, infection, cancer, uncontrollable seizure
- Generalized neuromuscular junction disease patients
- Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
- Patients enrolled in other studies
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- History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
- Botulinum toxin injection history in 6 months
- Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
- Otherwise clinically non-eligible patients
About this study
Official title: A Placebo Controlled, Cross-over, Double Blind, Randomized, Clinical Trial to Compare the Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.
- Conditions
- Adult Cerebral Palsy
- Being tested
- Meditoxin, Normal saline
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditoxinDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Placebo Group | Active comparator | Treatment on 0 day Placebo at 5th week Receives: Drug: Meditoxin |
| Placebo-Treatment Group | Active comparator | Placebo on 0 day Treatment at 5th week Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.
Measured: 0, 16, 32 weeks
Secondary outcomes (3)
Pain in numerical rating scale (NRS)
Pain in numerical rating scale (NRS)
Measured: Every 4 weeks, up to 32 weeks
Japanese Orthopaedic Association (JOA) score
Change of Japanese Orthopaedic Association (JOA) score from baseline Japanese Orthopaedic Association (JOA) score at 0 week.
Measured: Every 4 weeks, up to 32 weeks
Goal attainment scale
Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks.
Measured: 4, 12, 20, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keewon Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860196
- Sponsor's protocol ID
- MT_IT_009
- Acronym
- ATHETOID_CD
- Status last verified
- Aug 2017
- First submitted
- 13 May 2013
- Last updated
- 22 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Cross-over, Double Blind, Randomized, Clinical Trial to Compare the Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01860196
- Acronym / sponsor ID
- ATHETOID_CD / MT_IT_009
- Conditions
- Adult Cerebral Palsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 May 2013 (estimated)
- 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.
This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-Placebo Group | Active comparator | Drug: MeditoxinTreatment on 0 day Placebo at 5th week |
| Placebo-Treatment Group | Active comparator | Drug: Normal salinePlacebo on 0 day Treatment at 5th week |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult cerebral palsy patients over 20 years old
- Clinically diagnosed for cervical dystonia more than a year ago
- No improvement with antispasmodics for the last month
- Actively participated and gave informed consent
Key exclusion criteria (10 listed)
- Allergic to the botulinum toxin
- Limited range of motion in cervical spine
- Patients with fever, infection, cancer, uncontrollable seizure
- Generalized neuromuscular junction disease patients
- Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
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 |
|---|---|---|
| Meditoxin | Drug | Treatment-Placebo Group |
| Normal saline | Drug | Placebo-Treatment Group |
Primary outcome
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time frame: 0, 16, 32 weeks
Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.
3 secondary outcomes
Pain in numerical rating scale (NRS)
Time frame: Every 4 weeks, up to 32 weeks
Japanese Orthopaedic Association (JOA) score
Time frame: Every 4 weeks, up to 32 weeks
Goal attainment scale
Time frame: 4, 12, 20, 28 weeks
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 Aug 2017.
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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 4 study testing Meditoxin and Normal saline in people with Adult Cerebral Palsy, run by Seoul National University Hospital.
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 4 inclusion and 10 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 Aug 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (time frame: 0, 16, 32 weeks). 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 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.