Stroke With HemiparesisPhase 3NCT01422161
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
A Phase 3 study testing Botulinum Toxin commonly known as BOTOX® in people with Stroke With Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke With Hemiparesis
- What is being tested?
- Botulinum Toxin commonly known as BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2015
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to follow study instructions and likely to complete all required visits
- Ability to comply with the therapy protocol as assessed by the investigator
- 3 months post first-time unilateral stroke with right or left hemiparesis and complaints of unilateral hand dysfunction
- Must have ability to grasp and lift the test object
- Subjects must have upper extremity motor impairment
Who cannot join
- Known allergy or sensitivity to botulinum toxin type A (BOTOX).
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Concurrent participation in another investigational drug or device study or participation in another Botulinum toxin study in the 6 months prior to study.
- Treatment with botulinum toxin of any serotype in the 3 months prior to study enrollment
- Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
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- Infection or skin disorder at an anticipated injection site.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Current treatment with intrathecal baclofen.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke
The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).
Read the detailed description
Hemiparesis is the most common motor impairment after stroke that frequently leads to persistent deficits in hand function. This study investigates whether the application of botulinum toxin to a set of synergistically-acting hand muscles, in conjunction with task-specific therapy, will lead to reorganization and improved motor function in the stroke-involved hand. The investigators will use objective psychophysical measures of hand function and hand function rating scales to investigate if Botox in conjunction with task-specific therapy will lead to:
- improved motor execution,
- improved motor planning during a psychophysical two-finger grasping and lifting task with varying object weight, and
- increased hand function as assessed by the time taken to complete fine motor tasks.
- Conditions
- Stroke With Hemiparesis
- Being tested
- Botulinum Toxin commonly known as BOTOX®, Placebo
- Keywords
- Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Pathology, Physiopathology, Functional Laterality, Neuronal Plasticity, Psychomotor Performance, Biomechanics, Touch, Weight-Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin commonly known as BOTOX®Drug
Also called BOTOX®, Saline
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
PlaceboDrug
The control group will receive a placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin commonly known as BOTOX® | Experimental | Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. Receives: Drug: Botulinum Toxin commonly known as BOTOX® |
| Placebo | Placebo comparator | Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Taken to Form a Stable Grasp Pre-Treatment
Assessments are done on day 1, before the 1st Botulinum toxin injection.
They will be assessed for:
- Hand motor impairment (execution and planning) during a functional grasp and lift tasks.
- Hand function.
Measured: Day 1
Time Taken to Form a Stable Grasp Post Treatment
- Hand motor impairment (execution and planning) during a functional grasp and lift tasks.
- Hand function.
Measured: 90 Days
Secondary outcomes (4)
Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale
This scale has 3 points for each item. A zero is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.The five domains assessed by Fugl-Meyer scale are:
Motor function (Maximum score in upper limb = 66; Maximum score in lower limb = 34) Sensory function (Maximum score = 24) Balance (Maximum score = 14) Range of motion of joints (Maximum score = 44) Joint pain (Maximum score = 44)
Measured: Pre-Treatment, Day 90
Disability Measured by Modified Rankin Scale Score Post-Treatment
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).
Measured: 90 Days
Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment
Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully).
Measured: 1 Day and 90 Days
Disability Measured by Modified Rankin Scale Score Pre-Treatment
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).
Measured: Pre-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2015
- Study completionOct 2015
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 Stroke With HemiparesisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Preeti Raghavan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422161
- Sponsor's protocol ID
- 10-01126
- Other IDs
- 10-01126
- Status last verified
- Jun 2019
- First submitted
- 19 Aug 2011
- Last updated
- 20 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke
- ClinicalTrials.gov ID
- NCT01422161
- Acronym / sponsor ID
- 10-01126
- Conditions
- Stroke With Hemiparesis
- Keywords
- Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Pathology, Physiopathology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 31 May 2019
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 determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).
Detailed description
Hemiparesis is the most common motor impairment after stroke that frequently leads to persistent deficits in hand function. This study investigates whether the application of botulinum toxin to a set of synergistically-acting hand muscles, in conjunction with task-specific therapy, will lead to reorganization and improved motor function in the stroke-involved hand. The investigators will use objective psychophysical measures of hand function and hand function rating scales to investigate if Botox in conjunction with task-specific therapy will lead to:
- improved motor execution,
- improved motor planning during a psychophysical two-finger grasping and lifting task with varying object weight, and
- increased hand function as assessed by the time taken to complete fine motor tasks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin commonly known as BOTOX® | Experimental | Drug: Botulinum Toxin commonly known as BOTOX®Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. |
| Placebo | Placebo comparator | Drug: PlaceboSome subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to follow study instructions and likely to complete all required visits
- Ability to comply with the therapy protocol as assessed by the investigator
- 3 months post first-time unilateral stroke with right or left hemiparesis and complaints of unilateral hand dysfunction
- Must have ability to grasp and lift the test object
- Subjects must have upper extremity motor impairment
Key exclusion criteria (12 listed)
- Known allergy or sensitivity to botulinum toxin type A (BOTOX).
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Concurrent participation in another investigational drug or device study or participation in another Botulinum toxin study in the 6 months prior to study.
- Treatment with botulinum toxin of any serotype in the 3 months prior to study enrollment
- Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
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 commonly known as BOTOX®Also: BOTOX®, SalineA total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. There will be 1 treatment cycle during the 9 week study. | Drug | Botulinum Toxin commonly known as BOTOX® |
| PlaceboThe control group will receive a placebo injection. | Drug | Placebo |
Primary outcome
Time Taken to Form a Stable Grasp Pre-Treatment
Time frame: Day 1
Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for: * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.
Time Taken to Form a Stable Grasp Post Treatment
Time frame: 90 Days
* Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.
4 secondary outcomes
Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale
Time frame: Pre-Treatment, Day 90
Disability Measured by Modified Rankin Scale Score Post-Treatment
Time frame: 90 Days
Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment
Time frame: 1 Day and 90 Days
Disability Measured by Modified Rankin Scale Score Pre-Treatment
Time frame: Pre-Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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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.
Preeti Raghavan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin commonly known as BOTOX® in people with Stroke With Hemiparesis, run by NYU Langone Health at 1 site in United States.
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 5 inclusion and 12 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 31 May 2019). 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?
Time Taken to Form a Stable Grasp Pre-Treatment (time frame: Day 1). 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 20 Jun 2019.