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Cervical DystoniaPhase 3NCT00288509

Open-label Extension 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 18 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 assess longer term safety and effectiveness of Dysport®. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
18 sitesin 2 countries
Study dates
Feb 2006to Jan 2008
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

  • Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
  • Returned to pre-treatment status as judged by the Investigator

Who cannot join

  • Pure anterocollis or pure retrocollis
  • Known antibodies to botulinum toxin type A
  • Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
  • Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States14 sites

  • Albany Medical Center

    Albany, New York, 12205

  • Emory University School of Medicine, Wesley Woods Health Center

    Atlanta, Georgia, 30329

  • University of Texas Southwest Medical Center, Movement Disorder Clinic

    Dallas, Texas, 75309

  • The Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708

  • University of Florida, Dept of Neurology

    Gainesville, Florida, 32610

  • Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic

    Houston, Texas, 77030

  • University of Iowa, Dept of Neurology

    Iowa City, Iowa, 52242

  • USC School of Medicine

    Los Angeles, California, 90033

  • University of Miami, Dept of Neurology

    Miami, Florida, 33136

  • Beth Israel Medical Center

    New York, New York, 10003

  • Columbia University Medical Center, Neurological Institute

    New York, New York, 10032

  • Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Wayne State University Medical Center

    Southfield, Michigan, 48034

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, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia

The aim of this study is to assess longer term safety and effectiveness of Dysport®.

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®)

    In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety \& efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.

Study groups in NCT00288509
Study groupRoleWhat they receive
DysportExperimental250-1000 units
Receives: Biological: Botulinum toxin type A

What is being measured

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

  1. Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline

    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. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.

    Measured: Week 4 follow-up visit

Secondary outcomes (3)

  1. Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline

    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 severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.

    Measured: Week 4 follow-up visit

  2. Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline

    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 disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.

    Measured: Week 4 follow-up visit

  3. Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline

    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 pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at 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.

  1. First posted8 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288509
Sponsor's protocol ID
Y-47-52120-731
Other IDs
2005-002429-29, 2005
Status last verified
Sep 2022
First submitted
7 Feb 2006
Last updated
28 Sep 2022
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

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 18 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 18 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. 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 2 Apr 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?

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?

On the ClinicalTrials.gov record for NCT00288509, 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.

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