Cervical DystoniaCDNISLongtermNCT01840462
Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]
An observational study of Cervical Dystonia, run by Ipsen at 2 sites in 2 countries.
Trial summary
The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Dystonia
- Type of treatment
- Injection or infusion
- How many people
- 372 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to Mar 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from cervical dystonia
Who may be able to join
- Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
- Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
- With the intention to be treated with Dysport®
Who cannot join
- The subject has already been included in this study
- Participation in an interventional trial
- Suffering from anterocollis or retrocollis as primary component
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)
The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.
- Conditions
- Cervical Dystonia
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects naïve to botulinum toxin A (BoNT-A) treatment | Patients naïve to botulinum toxin A treatment | |
| Subjects pre-treated with botulinum toxin A (BoNT-A) injection | Patients pre-treated with botulinum toxin A for at least 2 years. 4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tsui scores
The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
Measured: Baseline and 12 weeks post-injection Cycle 2
Secondary outcomes (3)
Change in Tsui scores
The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
Measured: Baseline and 12 weeks post-injection Cycle 1
Change in Tsui scores
The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
Measured: Baseline and 12 weeks post-injection Cycle 3
Change in Tsui scores
The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
Measured: Baseline and 12 weeks post-injection Cycle 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840462
- Sponsor's protocol ID
- A-94-52120-165
- Acronym
- CDNISLongterm
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2013
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)
- ClinicalTrials.gov ID
- NCT01840462
- Acronym / sponsor ID
- CDNISLongterm / A-94-52120-165
- Conditions
- Cervical Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Apr 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.
The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects naïve to botulinum toxin A (BoNT-A) treatment | – | –Patients naïve to botulinum toxin A treatment |
| Subjects pre-treated with botulinum toxin A (BoNT-A) injection | – | –Patients pre-treated with botulinum toxin A for at least 2 years. 4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from cervical dystonia
Key inclusion criteria (3 listed)
- Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
- Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
- With the intention to be treated with Dysport®
Key exclusion criteria (3 listed)
- The subject has already been included in this study
- Participation in an interventional trial
- Suffering from anterocollis or retrocollis as primary component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Tsui scores
Time frame: Baseline and 12 weeks post-injection Cycle 2
The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
3 secondary outcomes
Change in Tsui scores
Time frame: Baseline and 12 weeks post-injection Cycle 1
Change in Tsui scores
Time frame: Baseline and 12 weeks post-injection Cycle 3
Change in Tsui scores
Time frame: Baseline and 12 weeks post-injection Cycle 4
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 14 Jan 2019.
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia, run by Ipsen at 2 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 3 inclusion and 3 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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.
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?
Change in Tsui scores (time frame: Baseline and 12 weeks post-injection Cycle 2). 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 14 Jan 2019.