Cervical DystoniaPhase 4NCT00950664
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
A Phase 4 study testing Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) in people with Cervical Dystonia, run by Seoul National University Hospital at 7 sites in South Korea.
Trial summary
1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia. 2. double blind, randomised, multi center, crossover study Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Aug 2009to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age of both genders,
- Cervical dystonia
- symptoms with a minimum duration of 18 months,
- Negative pregnancy test in sexually active women,
- Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).
Who cannot join
- Patient with cervical contractures
- Known significant underlying dysphasia
- Patients who have received botulinum toxin treatment within the past 4 months.
- Contraindication to botulinum toxin treatment
- Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS …)
- Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,
Show all 11Show fewer
- Patients who required more than 500 units of Dysport or 200 units of Botox.
- Any concomitant treatment that could interfere with the action of botulinum toxin,
- Subjects having participated within the last 3 months or currently participating in an investigational drug study,
- Pregnancy,
- Lactation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Dong-A University Hospital
Busan, 602-715
Bundang Seoul Natiuonal University Hospital
Seongnam-si, Gyeonggi-do, 463-070
Hanyang University Hospital
Seoul, 133-792
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Boramae City Hospital
Seoul, 156-707
Seoul National University Hospital
Seoul
About this study
Official title: A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia
- to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
- double blind, randomised, multi center, crossover study
Read the detailed description
- Prospective, randomized, head-to-head, double-blind, cross-over study.
- Total patients: A group 51, B group 51
- Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
- Compare the TSUI change score from baseline to 4 weeks after injection.
- Conditions
- Cervical Dystonia
- Being tested
- Dysport® (abobotulinumtoxinA), Botox® (onabotulinumtoxinA)
- Keywords
- cervical dystonia, botulinum toxin
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport® (abobotulinumtoxinA)Drug
Also called Dysport® (abobotulinumtoxinA)injection
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Botox® (onabotulinumtoxinA)Drug
Also called Botox® (onabotulinumtoxinA)injection
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
| Study group | Role | What they receive |
|---|---|---|
| Dysport® to Botox® | Experimental | Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) Receives: Drug: Dysport® (abobotulinumtoxinA); Drug: Botox® (onabotulinumtoxinA) |
| Botox® to Dysport® | Experimental | Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) Receives: Drug: Dysport® (abobotulinumtoxinA); Drug: Botox® (onabotulinumtoxinA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Total Tsui Score at 4 Weeks From Baseline
Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor.
Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.
Measured: 4 weeks after injection from baseline
Secondary outcomes (3)
Reduction of Total TWSTRS Score at 4 Weeks From Baseline
TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD).
The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain.
(range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS.
Measured: 4 weeks after injection from baseline
CGI-I (Clinical Global Impression of Illness)
The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I)
1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'.
Measured: 4, 8, 12 and 16 weeks after injection
PGI-I (Patient's Global Impression of Improvement)
The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)
1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated
Measured: 4, 8, 12 and 16 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen, Medical Research Collaborating Center, Seoul, Korea
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
- Investigators
- Beom S Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950664
- Sponsor's protocol ID
- H-0902-049-272
- Status last verified
- Jun 2017
- First submitted
- 29 Jul 2009
- Last updated
- 5 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.
PubMed 25476727
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00950664
- Acronym / sponsor ID
- H-0902-049-272
- Conditions
- Cervical Dystonia
- Keywords
- cervical dystonia, botulinum toxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ipsen, Medical Research Collaborating Center, Seoul, Korea
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
- double blind, randomised, multi center, crossover study
Detailed description
- Prospective, randomized, head-to-head, double-blind, cross-over study.
- Total patients: A group 51, B group 51
- Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
- Compare the TSUI change score from baseline to 4 weeks after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysport® to Botox® | Experimental | Drug: Dysport® (abobotulinumtoxinA), Drug: Botox® (onabotulinumtoxinA)Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) |
| Botox® to Dysport® | Experimental | Drug: Dysport® (abobotulinumtoxinA), Drug: Botox® (onabotulinumtoxinA)Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age of both genders,
- Cervical dystonia
- symptoms with a minimum duration of 18 months,
- Negative pregnancy test in sexually active women,
- Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).
Key exclusion criteria (11 listed)
- Patient with cervical contractures
- Known significant underlying dysphasia
- Patients who have received botulinum toxin treatment within the past 4 months.
- Contraindication to botulinum toxin treatment
- Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS …)
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 |
|---|---|---|
| Dysport® (abobotulinumtoxinA)Also: Dysport® (abobotulinumtoxinA)injectionCross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units | Drug | Botox® to Dysport®, Dysport® to Botox® |
| Botox® (onabotulinumtoxinA)Also: Botox® (onabotulinumtoxinA)injectionCross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units | Drug | Botox® to Dysport®, Dysport® to Botox® |
Primary outcome
Reduction of Total Tsui Score at 4 Weeks From Baseline
Time frame: 4 weeks after injection from baseline
Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor. Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.
3 secondary outcomes
Reduction of Total TWSTRS Score at 4 Weeks From Baseline
Time frame: 4 weeks after injection from baseline
CGI-I (Clinical Global Impression of Illness)
Time frame: 4, 8, 12 and 16 weeks after injection
PGI-I (Patient's Global Impression of Improvement)
Time frame: 4, 8, 12 and 16 weeks after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25476727Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.
- Individual participant dataSharing planned: No
Related trials for Cervical Dystonia
Enrolling by invitationPhase 2
Accelerating TMS for Cervical Dystonia
Isolated Cervical Dystonia
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
Recruiting
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
Cervical Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
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.
Beom S Jeon, MD, PhD principal investigator
Seoul National University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) in people with Cervical Dystonia, run by Seoul National University Hospital at 7 sites 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 5 inclusion and 11 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction of Total Tsui Score at 4 Weeks From Baseline (time frame: 4 weeks after injection from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950664, which also lists 1 linked publication.
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 5 Jul 2017.