StrokePhase 2NCT00076687
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
A Phase 2 study testing botulinum toxin Type A and saline in people with Stroke and Muscle Spasticity, run by Allergan at 4 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Muscle Spasticity, Motor Neuron Disease
- What is being tested?
- botulinum toxin Type A and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2003to Aug 2009
- Phase
- Phase 2
- 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
- Abnormal pulmonary function test results;
- focal, upper limb spasticity, upper motor neuron syndrome
Who cannot join
- Previous exposure to botulinum toxin of any serotype
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity
- Conditions
- Stroke, Muscle Spasticity, Motor Neuron Disease
- Being tested
- botulinum toxin Type A, saline
- Medical subject headings
- Stroke, Muscle Spasticity, Motor Neuron Disease
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 BOTOX®
botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
botulinum toxin Type ABiological
Also called BOTOX®
botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
salineDrug
Saline injection at Day 1, Week 12, Week 18
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: botulinum toxin Type A |
| 2 | Experimental | Not described Receives: Biological: botulinum toxin Type A |
| 3 | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Forced Vital Capacity (FVC)
Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Measured: Baseline, Week 6
Change From Baseline in Forced Expiratory Volume (FEV1)
Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Measured: Baseline, Week 6
Secondary outcomes (2)
Change From Baseline in FEV1/FVC Ratio
Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.
Measured: Baseline, Week 6
Change From Baseline in Ashworth Scale
Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2004 (estimated)
- Study startOct 2003
- Primary completionAug 2009
- Study completionAug 2009
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.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076687
- Sponsor's protocol ID
- 191622-057
- Status last verified
- Aug 2011
- First submitted
- 29 Jan 2004
- Last updated
- 3 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
- ClinicalTrials.gov ID
- NCT00076687
- Acronym / sponsor ID
- 191622-057
- Conditions
- Stroke, Muscle Spasticity, Motor Neuron Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Feb 2004 (estimated)
- Results
- Posted 3 Oct 2011
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 this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: botulinum toxin Type A |
| 2 | Experimental | Biological: botulinum toxin Type A |
| 3 | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Abnormal pulmonary function test results;
- focal, upper limb spasticity, upper motor neuron syndrome
Key exclusion criteria (1 listed)
- Previous exposure to botulinum toxin of any serotype
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: BOTOX®botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18 | Biological | 1 |
| botulinum toxin Type AAlso: BOTOX®botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18 | Biological | 2 |
| salineSaline injection at Day 1, Week 12, Week 18 | Drug | 3 |
Primary outcome
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, Week 6
Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Change From Baseline in Forced Expiratory Volume (FEV1)
Time frame: Baseline, Week 6
Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
2 secondary outcomes
Change From Baseline in FEV1/FVC Ratio
Time frame: Baseline, Week 6
Change From Baseline in Ashworth Scale
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 study director
Allergan
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing botulinum toxin Type A and saline in people with Stroke and Muscle Spasticity, run by Allergan at 4 sites in 4 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 2 inclusion and 1 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 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Czechia, Hungary, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Oct 2011). 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?
Change From Baseline in Forced Vital Capacity (FVC) (time frame: Baseline, Week 6). 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 3 Oct 2011.