Upper Limb Spasticity After StrokeDECIDENCT01239628
A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke
An observational study of Upper Limb Spasticity After Stroke, run by Ipsen at 11 sites in Belgium.
Trial summary
The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Spasticity After Stroke
- How many people
- 45 participants
- Where
- 11 sitesBelgium
- Study dates
- Dec 2010to Dec 2015
- 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 with a history of stroke, suffering from upper limb spasticity
Who may be able to join
- Subject able to comply with the protocol
- Provision of written informed consent prior to collecting the data
- Male or female patients of 18 years or older
- Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated
Who cannot join
- The subject has already been included in this survey
- Patients who already received BoNT-A treatment for upper limb spasticity
- Patients with known intolerance for BoNT-A
- Subjects unable to comply with the protocol
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
St- Augustinus
Antwerp
ZNA Middelheim
Antwerp
AZ St-Jan
Bruges, 8000
RevalidatieZiekenhuis RevArte
Edegem
AZ Sint Lucas
Ghent, 9000
Revalidatiecentrum St Ursula
Herk-de-Stad
ZOL, Campus Sint Barbara
Lanaken
Heilig Hart Ziekenhuis
Lier
Hôpital Marie Curie
Lodelinsart
CHU Leonardo da Vinci
Montigny-le-Tilleul
CHPLT Peltzer
Verviers
About this study
Official title: A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)
The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.
- Conditions
- Upper Limb Spasticity After Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of the injection intervals
Measured: 3 years
Documentation of treatment modalities
Measured: 3 years
Secondary outcomes (4)
Documentation of the main reason(s) for change in injection intervals
Measured: 3 years
Documentation of the main reason(s) for dose change(s)
Measured: 3 years
Documentation of the patient satisfaction with the treatment
Measured: 3 years
Documentation of the physician satisfaction with the treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Participant enrolment was lower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Spasticity After StrokeStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Neurology, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239628
- Sponsor's protocol ID
- A-48-52120-152
- Acronym
- DECIDE
- Status last verified
- Mar 2020
- First submitted
- 10 Nov 2010
- 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
- A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)
- ClinicalTrials.gov ID
- NCT01239628
- Acronym / sponsor ID
- DECIDE / A-48-52120-152
- Conditions
- Upper Limb Spasticity After Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Participant enrolment was lower than expected
- Enrolment
- 45 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Nov 2010 (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 purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of stroke, suffering from upper limb spasticity
Key inclusion criteria (4 listed)
- Subject able to comply with the protocol
- Provision of written informed consent prior to collecting the data
- Male or female patients of 18 years or older
- Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated
Key exclusion criteria (4 listed)
- The subject has already been included in this survey
- Patients who already received BoNT-A treatment for upper limb spasticity
- Patients with known intolerance for BoNT-A
- Subjects unable to comply with the protocol
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
Documentation of the injection intervals
Time frame: 3 years
Documentation of treatment modalities
Time frame: 3 years
4 secondary outcomes
Documentation of the main reason(s) for change in injection intervals
Time frame: 3 years
Documentation of the main reason(s) for dose change(s)
Time frame: 3 years
Documentation of the patient satisfaction with the treatment
Time frame: 3 years
Documentation of the physician satisfaction with the treatment
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Participant enrolment was lower than expected). Results are not available in the source record.
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.
Medical Director, Neurology study director
Ipsen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Spasticity After Stroke, run by Ipsen at 11 sites in Belgium.
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 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: stopped early, 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 11 sites in Belgium. 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 was stopped early (reason given: Participant enrolment was lower than expected). Results are not available in the source record.
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?
Documentation of the injection intervals (time frame: 3 years). The study lists 2 primary outcomes in all. 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.