Cervical DystoniaPhase 3NCT00257660

Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

A Phase 3 study testing Botulinum toxin type A in people with Cervical Dystonia, run by Ipsen at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cervical Dystonia
What is being tested?: Botulinum toxin type A
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 22 sitesin 2 countries
Study dates: 10 Oct 2005to Sep 2006
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Who cannot join

Pure anterocollis or pure retrocollis
In apparent remission from cervical dystonia
Previous poor response to the last two botulinum toxin type A or type B treatments
Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin

Trial locations and contacts

22 sites in 2 countries.

Country

City, postcode or hospital

22 sites in 2 countries

United States18 sites

Albany Medical Center
Albany, New York
Emory University
Atlanta, Georgia
University of Maryland Medical Center
Baltimore, Maryland
Rush University Medical Center
Chicago, Illinois
University of Texas Southwest
Dallas, Texas
Parkinson's and Movement Disorder Institute
Fountain Valley, California
University of Florida
Gainesville, Florida
Baylor College of Medicine
Houston, Texas
University of Iowa
Iowa City, Iowa
USC School of Medicine
Los Angeles, California, 90033
University of Miami
Miami, Florida
Beth Israel Medical Center
New York, New York, 10003
Columbia University
New York, New York
St. Joseph's Hospital and Medical Center
Phoenix, Arizona
Allegeheny General
Pittsburgh, Pennsylvania
Swedish Neuroscience
Seattle, Washington
Wayne State University Medical Center
Southfield, Michigan
Wake Forest University
Winston-Salem, North Carolina

Other trials in United States

Russia4 sites

Scientific Research Institute of Neurology, RAMS
Moscow, 123367
Clinic "Cecil Plus"
Moscow, 125047
Municipal Multi-Speciality Hospital #2
Saint Petersburg, 194354
St Petersburg Pavlov State Medical University
Saint Petersburg, 197022

Other trials in Russia

About this study

Official title: A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Conditions: Cervical Dystonia
Being tested: Botulinum toxin type A, Placebo
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 ABiological
Also called AbobotulinumtoxinA (Dysport®)
500 units
PlaceboDrug
500 units

Study groups in NCT00257660
Study group	Role	What they receive
1	Experimental	Drug: abobotulinumtoxinA (Dysport®) Receives: Biological: Botulinum toxin type A
2	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Measured: Baseline and Week 4

Secondary outcomes (11)

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Measured: Baseline and Week 8
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Measured: Baseline and Week 12
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Measured: Baseline and Week 4
Investigator VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Measured: Baseline and Week 4
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Measured: Baseline and Week 8
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Measured: Baseline and week 8
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Measured: Baseline and week 12
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Measured: Baseline and week 12
SF-36 Mental Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
Measured: Week 8
SF-36 Physical Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Measured: Week 8
Number of Participants Considered by the Investigator to be Overall Treatment Successes
The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 2005Sep 2006

First posted23 Nov 2005 (estimated)
Study start10 Oct 2005
Primary completionSep 2006
Study completionSep 2006

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 (2)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 IpsenThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00257660
Sponsor's protocol ID: Y-47-52120-051
Other IDs: 2005-000709-70, 2005
Status last verified: Sep 2022
First submitted: 22 Nov 2005
Last updated: 28 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Publications

Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31.
PubMed 20359934
Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150.
PubMed 25324317

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Cervical Dystonia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
ClinicalTrials.gov ID: NCT00257660
Acronym / sponsor ID: Y-47-52120-051
Conditions: Cervical Dystonia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: 10 Oct 2005 (actual)
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 23 Nov 2005 (estimated)
Results: Posted 10 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Botulinum toxin type ADrug: abobotulinumtoxinA (Dysport®)
2	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Key exclusion criteria (4 listed)

Pure anterocollis or pure retrocollis
In apparent remission from cervical dystonia
Previous poor response to the last two botulinum toxin type A or type B treatments
Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin

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 AAlso: AbobotulinumtoxinA (Dysport®)500 units	Biological	1
Placebo500 units	Drug	2

Primary outcome

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time frame: Baseline and Week 4
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.

11 secondary outcomes

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time frame: Baseline and Week 8
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Time frame: Baseline and Week 12
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
Time frame: Baseline and Week 4
Investigator VAS for CD Symptom Assessment
Time frame: Baseline and Week 4
Subject VAS for CD Symptom Assessment
Time frame: Baseline and Week 8
Investigator's VAS for CD Symptom Assessment
Time frame: Baseline and week 8
Subject VAS for CD Symptom Assessment
Time frame: Baseline and week 12
Investigator's VAS for CD Symptom Assessment
Time frame: Baseline and week 12
SF-36 Mental Health Summary Score
Time frame: Week 8
SF-36 Physical Health Summary Score
Time frame: Week 8
Number of Participants Considered by the Investigator to be Overall Treatment Successes
Time frame: Week 12

Results and safety

Results posted to the registry on 10 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dysport 500 Units	55	45
Placebo	61	38

Primary outcome: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

Time frame: Baseline and Week 4. Mean (Standard Deviation). Unit: points on a scale

Measure	Dysport 500 Units n = 51	Placebo n = 58
Change in TWSTRS total score	-13.99 (12.33)	-5.23 (9.33)
Baseline TWSTRS total score	43.83 (7.97)	45.81 (8.78)
Week 4 TWSTRS total score	30.04 (12.65)	40.22 (11.75)

Dysport 500 Units vs Placebo: Mean Difference (Net): -8.84 (95% CI -12.94 to -4.74), p <0.0001, ANCOVA

Population analysed: The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dysport 500 Units	0 of 55 (0%)	11 of 55 (20%)	Not reported
Placebo	1 of 61 (1.6%)	5 of 61 (8.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20359934Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31.
Derived from this study: PubMed 25324317Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

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.

Ipsen Medical Director study director

Ipsen

22 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A in people with Cervical Dystonia, run by Ipsen at 22 sites in 2 countries.

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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Russia. 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?

Yes. Results are posted in the registry (first posted 10 May 2010). 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?

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (time frame: Baseline and Week 4). 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 NCT00257660, which also lists 2 linked publications.

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 28 Sep 2022.