Post-stroke Arm SpasticityEARLYBIRDNCT01840475
Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)
An observational study of Post-stroke Arm Spasticity, run by Ipsen at 5 sites in 5 countries.
Trial summary
Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms. The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Post-stroke Arm Spasticity
- Type of treatment
- Injection or infusion
- How many people
- 302 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Mar 2013to 6 Feb 2018
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from post-stroke arm spasticity registered with Neurological clinics, Rehab centers with BoNT out-patient clinics and neurological practices.
Who may be able to join
- Written informed consent prior to data collection
- Hemiparesis and clinically relevant upper limb post-stroke spasticity
- Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC
- BoNT naïve or pre-treated with any BoNT product
Who cannot join
- Recurrent stroke
- Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.
Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms.
The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.
- Conditions
- Post-stroke Arm Spasticity
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 |
|---|---|---|
| Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve | Subjects naïve to BoNT-A treatment. | |
| Botulinum toxin type A (BoNT-A) Pre-treated | Subjects pre-treated with BoNT-A. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics [SmPC]). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).
"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A.
Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).
Measured: Final study visit: approximately 20 months after first visit
Secondary outcomes (1)
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).
"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A.
Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).
Measured: Approximately every 4 months starting from baseline up to 2 years
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 startMar 2013
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Arm SpasticityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 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
- NCT01840475
- Sponsor's protocol ID
- A-94-52120-174
- Acronym
- EARLYBIRD
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2013
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.
- ClinicalTrials.gov ID
- NCT01840475
- Acronym / sponsor ID
- EARLYBIRD / A-94-52120-174
- Conditions
- Post-stroke Arm Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (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.
Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms.
The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve | – | –Subjects naïve to BoNT-A treatment. |
| Botulinum toxin type A (BoNT-A) Pre-treated | – | –Subjects pre-treated with BoNT-A. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics [SmPC]). |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from post-stroke arm spasticity registered with Neurological clinics, Rehab centers with BoNT out-patient clinics and neurological practices.
Key inclusion criteria (4 listed)
- Written informed consent prior to data collection
- Hemiparesis and clinically relevant upper limb post-stroke spasticity
- Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC
- BoNT naïve or pre-treated with any BoNT product
Key exclusion criteria (2 listed)
- Recurrent stroke
- Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®
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
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).
Time frame: Final study visit: approximately 20 months after first visit
"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A. Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).
1 secondary outcome
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).
Time frame: Approximately every 4 months starting from baseline up to 2 years
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 31 Mar 2020.
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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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-stroke Arm Spasticity, run by Ipsen at 5 sites in 5 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 4 inclusion and 2 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, France, Germany, Netherlands, Switzerland. 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?
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated). (time frame: Final study visit: approximately 20 months after first visit). 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 31 Mar 2020.