Cervical DystoniaPhase 3NCT01753336
Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
A Phase 3 study testing Botulinum toxin type A in people with Cervical Dystonia, run by Ipsen at 41 sites in United States.
Trial summary
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169). 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
- 112 participants
- Where
- 41 sitesUnited States
- Study dates
- Mar 2013to Oct 2015
- 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 Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
- Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport® for CD
Who cannot join
- Diagnosis of pure retrocollis or pure anterocollis
- Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
- Known hypersensitivity to BoNT or related compounds, or any component in the study drug formulation
- Allergy to cow's milk protein
- Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that could interfere with the TWSTRS scoring
- Total body weight <95 lbs (43.09 kg)
Show all 17Show fewer
- Previous phenol injections to the neck muscles
- Previous myotomy or denervation surgery involving the neck or shoulder region or deep brain stimulation to treat CD
- Cervical contracture that limited passive range of motion
- Physiotherapy initiated <4 weeks before study entry or expected to be initiated during the study
- Treatment with aminoglycoside antibiotics within 30 days prior to study treatment
- Current or expected requirement for concomitant medication that could interfere with the evaluation of study treatment
- Pregnant and/or lactating females
- Females of childbearing potential with a positive prestudy urine pregnancy test (a positive urine pregnancy test could be confirmed by a serum pregnancy test at the discretion of the investigator) and subjects, or their partners, who did not agree to use adequate contraception (hormonal or barrier method of birth control) prior to injection of study treatment and for the duration of study participation. Nonchildbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy
- Individuals who had family or employee relationship to study site staff or sponsor staff involved in the conduct of the study
- Any medical condition that could, as judged by the investigator, compromise compliance with the objectives and procedures of this protocol or preclude the administration of BoNT, including swallowing and other respiratory abnormality.
- Subjects who were unable and/or unwilling to comply fully with the protocol and the study instructions, as judged by the investigator
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Emory University
Atlanta, Georgia, 30329
NeuroTrials Research Inc.
Atlanta, Georgia, 30342
North Texas Movement Disorders Institute
Bedford, Texas, 76201
East Bay Physician's Group
Berkeley, California, 94705
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Tufts Medical Center
Boston, Massachusetts, 02111
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, 45267
Rehabilitation Consultants, PA
Eagan, Minnesota, 55121
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut, 06824
Advanced Neurosciences Research
Fort Collins, Colorado, 80528
Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina, 27405
Penn State Hershey Neurology
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Kansas City Bone & Joint Clinic
Kansas City, Kansas, 66211
Kingston Neurological Associates
Kingston, New York, 12401
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California, 92354
USC Keck School of Medicine
Los Angeles, California, 90033
Yale Medical Group, Yale University
New Haven, Connecticut, 06520
The Ichan School of Medicine at Mount Sinai
New York, New York, 10029
International Clinical Research Institute
Overland Park, Kansas, 66210
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514
Island Neurological Associates
Plainview, New York, 11803
Parkinson's Treatment Center of SW Florida
Port Charlotte, Florida, 33980
Coastal Neurology, PA
Port Royal, South Carolina, 29935
OHSU Center for Health and Healing
Portland, Oregon, 97239
Sutter Cancer Center
Sacramento, California, 95816
UC Davis Medical Center
Sacramento, California, 95817
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, 85258
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, 08084
Atlantic Neuroscience Institute
Summit, New Jersey, 07901
Puget Sound Neurology
Tacoma, Washington, 98409
USF HealthParkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613
University of Arizona
Tucson, Arizona, 85724
Guilford Neurologic Associates
West Palm Beach, Florida, 33407
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL Dilution In Adults With Cervical Dystonia
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
- Conditions
- Cervical Dystonia
- Being tested
- Botulinum toxin type A
- 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®)
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| Dysport® | Experimental | Dysport®, up to 500 units (U)/vial using 2mL dilution Receives: Biological: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Measured: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Secondary outcomes (5)
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.
Measured: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Treatment Response in Treatment Cycle 3 Week 4.
Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.
Measured: Week 4 Treatment Cycle 3
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Measured: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Measured: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Measured: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionOct 2015
- Study completionOct 2015
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Neurology, M.D., Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753336
- Sponsor's protocol ID
- A-TL-52120-170
- Status last verified
- Jul 2019
- First submitted
- 17 Dec 2012
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dashtipour K, Wietek S, Rubin B, Maisonobe P, Bahroo L, Trosch R. AbobotulinumtoxinA using 2-mL dilution (500 U/2-mL) maintains durable improvement across multiple treatment cycles. J Clin Mov Disord. 2020 Aug 31;7:8. doi: 10.1186/s40734-020-00090-x. eCollection 2020.
PubMed 32884828
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL Dilution In Adults With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT01753336
- Acronym / sponsor ID
- A-TL-52120-170
- Conditions
- Cervical Dystonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 4 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysport® | Experimental | Biological: Botulinum toxin type ADysport®, up to 500 units (U)/vial using 2mL dilution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
- Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport® for CD
Key exclusion criteria (17 listed)
- Diagnosis of pure retrocollis or pure anterocollis
- Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
- Known hypersensitivity to BoNT or related compounds, or any component in the study drug formulation
- Allergy to cow's milk protein
- Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that could interfere with the TWSTRS scoring
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®)Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles | Biological | Dysport® |
Primary outcome
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Time frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
5 secondary outcomes
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Time frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Treatment Response in Treatment Cycle 3 Week 4.
Time frame: Week 4 Treatment Cycle 3
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Time frame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Time frame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Time frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32884828Dashtipour K, Wietek S, Rubin B, Maisonobe P, Bahroo L, Trosch R. AbobotulinumtoxinA using 2-mL dilution (500 U/2-mL) maintains durable improvement across multiple treatment cycles. J Clin Mov Disord. 2020 Aug 31;7:8. doi: 10.1186/s40734-020-00090-x. eCollection 2020.
- A-TL-52120-169Link provided by the sponsor.
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.
Medical Director Neurology, M.D. study director
Ipsen
41 sites in 1 country: 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 41 sites in United States.
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 17 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. 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 4 May 2017). 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?
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. (time frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)). 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 NCT01753336, 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 7 Aug 2019.