StrokePhase 4NCT00178646
Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity
A Phase 4 study testing Botox in people with Stroke and Brain Injuries, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Stroke, Brain Injuries, Spasticity
- What is being tested?
- Botox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2002to Mar 2010
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Spasticity resulting from ABI (stroke, including vascular malformations, traumatic brain injury)
- Ashworth Score (resting) of at least 2 of the primary ankle plantarflexor (gastrocnemius)
- Onset of primary illness at least six months prior to study inclusion
- At least 12 years of age
Who cannot join
- Hypersensitivity or allergy to botulinum toxin
- History of myasthenia gravis or other neuromuscular disease
- Current use of aminoglycosides
- Botulinum toxin or phenol injection to study limb within six months prior to recruitment
- Current use of other spasmolytic drug, such as diazepam, baclofen, dantrolene, tizanidine
- Presence of contracture or significant muscle atrophy
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Hermann Hospital
Houston, Texas, 77030
Kessler Institute for Rehabiliation
West Orange, New Jersey, 07052
About this study
The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.
Read the detailed description
Spasticity is one of the most debilitating complications of neurologic conditions, such as stroke, brain injury, spinal cord injury, cerebral palsy, and multiple sclerosis. Although the exact pathophysiology is unknown, it is believed to result from an imbalance of ascending excitatory influences on and descending inhibitory components of the central nervous system. Clinically, spasticity manifests as abnormally increased muscle tone, associated with loss of range of motion, increased muscle stretch reflexes, clonus, weakness, and incoordination. If inadequately treated, spasticity leads to more disability and increase health care costs. Common complications of inadequately treated spasticity include joint and muscle contracture, pain, difficulty with performing activities of daily living and hygiene, and impaired transfers and ambulation.
Acquired brain injuries (ABI), including stroke, traumatic brain injury, and encephalopathy, often lead to long-term impairments, including spasticity. In severe cases, spasticity is difficult and frustrating to treat in this patient population, since the individuals may not tolerate the side effects of conventional therapies because of ABI-related deficits in arousal and cognition. Systemic medications, such as baclofen and tizanidine, are effective in controlling spasticity; however, they may also cause sleepiness and drowsiness, and impair memory and thinking processes---adverse effects that individuals with ABI may not tolerate.
Thus, "local" treatments, such as neurolysis and chemodenervation using botulinum toxin, have become superior treatment options in individuals with ABI, since they are devoid of the usual side effects of systemic medications. They are also effective in controlling spasticity, yet they do not impair arousal and cognition. The medical literature is replete with reports of the efficacy of botulinum toxin-A in the management of spasticity. Thus, the current challenge for clinicians and researchers at this time is to find ways to further enhance the efficacy of botulinum toxin. One way to achieve this is by exploiting certain properties of the toxin. Animal studies and clinical experience have shown that the effects of the drug is dose-dependent. One other property is the flexibility in preparing the volume of drug injected. Since botulinum toxin, as it is currently available (as BOTOX-A®) in the United States, requires reconstitution with preservative-free saline, there is flexibility for clinicians to manipulate the volume of solution that will be administered, without altering the dose.
We recently completed a trial comparing the effects of two volume preparations of BOTOX-A® on wrist and finger flexor spasticity of individuals with ABI. One group of patients received BOTOX-A® prepared as 100 units/cc, while another received BOTOX-A® prepared as 50 units/cc. Although there was no statistically significant difference between the two groups, there was a trend in favor of the group that received the higher volume, i.e.; they appeared to improve more based on decrease in muscle tone (measured by the Modified Ashworth Scale). This was compared by the clinician's global impression that the high volume group improved more. The latter measure achieved statistical significance. One possible reason for the absence of statistical significance was that the "high" volume (50 units/cc) was not high enough. Thus, we are proposing this study to investigate the comparative effects of three preparations of BOTOX-A®.
- Conditions
- Stroke, Brain Injuries, Spasticity
- Being tested
- Botox
- Keywords
- Stroke, Brain Injuries, Spasticity, Botulinum Toxins
- Medical subject headings
- Stroke, Brain Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Also called generic name: botulinum toxin type A
Botox 75-150 units, single treatment only
| Study group | Role | What they receive |
|---|---|---|
| 1 - Low Volume, High Dose | Experimental | Botox (onabotulinumtoxinA), 150 units prepared as 100 units per 1 ml of preservative-free normal saline Receives: Drug: Botox |
| 2 - High Volume, High Dose | Active comparator | Botox (onabotulinumtoxinA), 150 units prepared as 50 units per 1 ml of preservative-free normal saline Receives: Drug: Botox |
| 3 - High Volume, Low Dose | Other | Botox (onabotulinumtoxinA), 75 units prepared as 25 units per 1 ml of preservative-free normal saline Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spastic Hypertonia as Measured by the Ashworth Scale
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst:
0 - No increase in muscle tone
- - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- - More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed
- - Considerable increase in muscle tone, passive movement difficult
- - Limb in flexion or extension
Measured: Baseline
Spastic Hypertonia as Measured by the Ashworth Scale
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst:
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed
- Considerable increase in muscle tone, passive movement difficult
- Limb in flexion or extension
Measured: Four weeks
Spastic Hypertonia as Measured by the Ashworth Scale
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst:
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed
- Considerable increase in muscle tone, passive movement difficult
- Limb in flexion or extension
Measured: Eight Weeks
Spastic Hypertonia as Measured by the Ashworth Scale
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst:
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed
- Considerable increase in muscle tone, passive movement difficult
- Limb in flexion or extension
Measured: Twelve Weeks
Spastic Hypertonia as Measured by the Ashworth Scale
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst:
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed
- Considerable increase in muscle tone, passive movement difficult
- Limb in flexion or extension
Measured: Sixteen Weeks
Secondary outcomes (2)
Range of Motion as Measured by Goniometry
This outcome reports the angle formed during ankle dorsiflexion by an imaginary line drawn on the outer side of the leg with an imaginary line drawn on the outside of the foot. The angle changes as the ankle is curled up (dorsiflexed) or down (plantarflexed). Many people with stroke develop muscle tightness (a condition called spasticity) or contracture, which leads to ankle plantarflexion and results in a "foot drop" appearance and limits range of motion.
When the ankle is neutral and the foot is flat, the angle between the leg and the foot is roughly a right angle, and this neutral position is indicated as 0 degrees from the neutral position. If the foot is below the neutral position during maximum ankle dorsiflexion, then the angle reported is the number of degrees below the neutral position (reported as a negative value). If the foot is above the neutral position, then the angle reported is the number of degrees above the neutral position (positive value).
Measured: Baseline
Range of Motion as Measured by Goniometry
This outcome reports the angle formed during ankle dorsiflexion by an imaginary line drawn on the outer side of the leg with an imaginary line drawn on the outside of the foot. The angle changes as the ankle is curled up (dorsiflexed) or down (plantarflexed). Many people with stroke develop muscle tightness (a condition called spasticity) or contracture, which leads to ankle plantarflexion and results in a "foot drop" appearance and limits range of motion.
When the ankle is neutral and the foot is flat, the angle between the leg and the foot is roughly a right angle, and this neutral position is indicated as 0 degrees from the neutral position. If the foot is below the neutral position during maximum ankle dorsiflexion, then the angle reported is the number of degrees below the neutral position (reported as a negative value). If the foot is above the neutral position, then the angle reported is the number of degrees above the neutral position (positive value).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionMar 2010
- Study completionMar 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Gerard Francisco, The University of Texas Health Science Center, Houston
- Investigators
- Gerard E Francisco, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178646
- Sponsor's protocol ID
- HSC-MS-01-103
- Status last verified
- Jan 2021
- First submitted
- 12 Sep 2005
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Francisco GE, Boake C, Vaughn A. Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques. Am J Phys Med Rehabil. 2002 May;81(5):355-63. doi: 10.1097/00002060-200205000-00007.
PubMed 11964576
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity
- ClinicalTrials.gov ID
- NCT00178646
- Acronym / sponsor ID
- HSC-MS-01-103
- Conditions
- Stroke, Brain Injuries, Spasticity
- Keywords
- Stroke, Brain Injuries, Spasticity, Botulinum Toxins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.
Detailed description
Spasticity is one of the most debilitating complications of neurologic conditions, such as stroke, brain injury, spinal cord injury, cerebral palsy, and multiple sclerosis. Although the exact pathophysiology is unknown, it is believed to result from an imbalance of ascending excitatory influences on and descending inhibitory components of the central nervous system. Clinically, spasticity manifests as abnormally increased muscle tone, associated with loss of range of motion, increased muscle stretch reflexes, clonus, weakness, and incoordination. If inadequately treated, spasticity leads to more disability and increase health care costs. Common complications of inadequately treated spasticity include joint and muscle contracture, pain, difficulty with performing activities of daily living and hygiene, and impaired transfers and ambulation.
Acquired brain injuries (ABI), including stroke, traumatic brain injury, and encephalopathy, often lead to long-term impairments, including spasticity. In severe cases, spasticity is difficult and frustrating to treat in this patient population, since the individuals may not tolerate the side effects of conventional therapies because of ABI-related deficits in arousal and cognition. Systemic medications, such as baclofen and tizanidine, are effective in controlling spasticity; however, they may also cause sleepiness and drowsiness, and impair memory and thinking processes---adverse effects that individuals with ABI may not tolerate.
Thus, "local" treatments, such as neurolysis and chemodenervation using botulinum toxin, have become superior treatment options in individuals with ABI, since they are devoid of the usual side effects of systemic medications. They are also effective in controlling spasticity, yet they do not impair arousal and cognition. The medical literature is replete with reports of the efficacy of botulinum toxin-A in the management of spasticity. Thus, the current challenge for clinicians and researchers at this time is to find ways to further enhance the efficacy of botulinum toxin. One way to achieve this is by exploiting certain properties of the toxin. Animal studies and clinical experience have shown that the effects of the drug is dose-dependent. One other property is the flexibility in preparing the volume of drug injected. Since botulinum toxin, as it is currently available (as BOTOX-A®) in the United States, requires reconstitution with preservative-free saline, there is flexibility for clinicians to manipulate the volume of solution that will be administered, without altering the dose.
We recently completed a trial comparing the effects of two volume preparations of BOTOX-A® on wrist and finger flexor spasticity of individuals with ABI. One group of patients received BOTOX-A® prepared as 100 units/cc, while another received BOTOX-A® prepared as 50 units/cc. Although there was no statistically significant difference between the two groups, there was a trend in favor of the group that received the higher volume, i.e.; they appeared to improve more based on decrease in muscle tone (measured by the Modified Ashworth Scale). This was compared by the clinician's global impression that the high volume group improved more. The latter measure achieved statistical significance. One possible reason for the absence of statistical significance was that the "high" volume (50 units/cc) was not high enough. Thus, we are proposing this study to investigate the comparative effects of three preparations of BOTOX-A®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Low Volume, High Dose | Experimental | Drug: BotoxBotox (onabotulinumtoxinA), 150 units prepared as 100 units per 1 ml of preservative-free normal saline |
| 2 - High Volume, High Dose | Active comparator | Drug: BotoxBotox (onabotulinumtoxinA), 150 units prepared as 50 units per 1 ml of preservative-free normal saline |
| 3 - High Volume, Low Dose | Other | Drug: BotoxBotox (onabotulinumtoxinA), 75 units prepared as 25 units per 1 ml of preservative-free normal saline |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Spasticity resulting from ABI (stroke, including vascular malformations, traumatic brain injury)
- Ashworth Score (resting) of at least 2 of the primary ankle plantarflexor (gastrocnemius)
- Onset of primary illness at least six months prior to study inclusion
- At least 12 years of age
Key exclusion criteria (7 listed)
- Hypersensitivity or allergy to botulinum toxin
- History of myasthenia gravis or other neuromuscular disease
- Current use of aminoglycosides
- Botulinum toxin or phenol injection to study limb within six months prior to recruitment
- Current use of other spasmolytic drug, such as diazepam, baclofen, dantrolene, tizanidine
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 |
|---|---|---|
| BotoxAlso: generic name: botulinum toxin type ABotox 75-150 units, single treatment only | Drug | 1 - Low Volume, High Dose, 2 - High Volume, High Dose, 3 - High Volume, Low Dose |
Primary outcome
Spastic Hypertonia as Measured by the Ashworth Scale
Time frame: Baseline
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0 - No increase in muscle tone 1. - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. - More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. - Considerable increase in muscle tone, passive movement difficult 4. - Limb in flexion or extension
Spastic Hypertonia as Measured by the Ashworth Scale
Time frame: Four weeks
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension
Spastic Hypertonia as Measured by the Ashworth Scale
Time frame: Eight Weeks
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension
Spastic Hypertonia as Measured by the Ashworth Scale
Time frame: Twelve Weeks
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension
Spastic Hypertonia as Measured by the Ashworth Scale
Time frame: Sixteen Weeks
The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension
2 secondary outcomes
Range of Motion as Measured by Goniometry
Time frame: Baseline
Range of Motion as Measured by Goniometry
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11964576Francisco GE, Boake C, Vaughn A. Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques. Am J Phys Med Rehabil. 2002 May;81(5):355-63. doi: 10.1097/00002060-200205000-00007.
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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.
Gerard E Francisco, MD principal investigator
University of Texas
2 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 Botox in people with Stroke and Brain Injuries, run by The University of Texas Health Science Center, Houston at 2 sites 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 4 inclusion and 7 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2021). 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?
Spastic Hypertonia as Measured by the Ashworth Scale (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT00178646, 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 22 Jan 2021.