Cerebrovascular AccidentPhase 4NCT00216411
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
A Phase 4 study testing Botulinum toxin type A in people with Cerebrovascular Accident and Muscle Spasticity, run by Ipsen at 6 sites in Australia.
Trial summary
The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Muscle Spasticity
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 6 sitesAustralia
- Study dates
- Nov 2004to 20 Jul 2006
- Phase
- Phase 4
- 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
Who may be able to join
- The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
- The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
- The patient has the cognitive and communication ability to participate in the study.
Who cannot join
- Patients who have received botulinum toxin treatment within the past 120 days.
- Contraindication to botulinum toxin treatment.
- Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
- Patients who have previously been treated with phenol for their upper limb spasticity.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
St Josephs Hospital
Auburn, New South Wales, 2144
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Caulfield General Medical Centre
Caulfield, Victoria, 3162
Austin Health
Heidelberg, Victoria, 3084
Prince of Wales Hospital
Randwick, New South Wales, 2031
About this study
Official title: A Prospective Phase IV, Multicentre, Placebo-controlled Study to Demonstrate Changes in the Quality of Life Following DYSPORT Intramuscular Injection in the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.
- Conditions
- Cerebrovascular Accident, Muscle Spasticity
- Being tested
- Botulinum toxin type A, Placebo
- Medical subject headings
- Stroke, Muscle Spasticity
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®)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dysport | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary outcomes (7)
Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Change in the Modified Motor Assessment Scale
Change in patient disability and carer burden rating scale total score
Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Change in the degree of pain
Change in depression rating scale total score
Global assessment of benefit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2004
- Primary completion20 Jul 2006
- Study completion20 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216411
- Sponsor's protocol ID
- A-9B-52120-097
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jul 2019
- Results posted
- No
Publications
Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474.
PubMed 20111849
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase IV, Multicentre, Placebo-controlled Study to Demonstrate Changes in the Quality of Life Following DYSPORT Intramuscular Injection in the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT00216411
- Acronym / sponsor ID
- A-9B-52120-097
- Conditions
- Cerebrovascular Accident, Muscle Spasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- 20 Jul 2006 (actual)
- Study completion
- 20 Jul 2006 (actual)
- First posted
- 22 Sep 2005 (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 main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysport | Experimental | Biological: Botulinum toxin type A |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
- The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
- The patient has the cognitive and communication ability to participate in the study.
Key exclusion criteria (4 listed)
- Patients who have received botulinum toxin treatment within the past 120 days.
- Contraindication to botulinum toxin treatment.
- Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
- Patients who have previously been treated with phenol for their upper limb spasticity.
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®) | Biological | Dysport |
| Placebo | Drug | Placebo |
Primary outcome
Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
7 secondary outcomes
Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Change in the Modified Motor Assessment Scale
Change in patient disability and carer burden rating scale total score
Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Change in the degree of pain
Change in depression rating scale total score
Global assessment of benefit
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 29 Jul 2019.
- Derived from this study: PubMed 20111849Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474.
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A in people with Cerebrovascular Accident and Muscle Spasticity, run by Ipsen at 6 sites in Australia.
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 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).. 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 NCT00216411, 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 29 Jul 2019.