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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Low Volume, High Dose | Experimental | Botox (onabotulinumtoxinA), 150 units prepared as 100 units per 1 ml of preservative-free normal saline |
|
| 2 - High Volume, High Dose | Active Comparator | Botox (onabotulinumtoxinA), 150 units prepared as 50 units per 1 ml of preservative-free normal saline |
|
| 3 - High Volume, Low Dose | Other | Botox (onabotulinumtoxinA), 75 units prepared as 25 units per 1 ml of preservative-free normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | Botox 75-150 units, single treatment only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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
| 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
| Eight Weeks |
| Spastic Hypertonia as Measured by the Ashworth Scale |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria -
Exclusion Criteria -
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| Name | Affiliation | Role |
|---|---|---|
| Gerard E Francisco, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Institute for Rehabiliation | West Orange | New Jersey | 07052 | United States | ||
| Memorial Hermann Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11964576 | Background | 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. |
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33 were enrolled but 32 started, and this is because one participant who enrolled decided not to start the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Volume, High Dose | Botox, 150 units prepared as 100 units/ml Botox: Botox 75-150 units, single treatment only |
| FG001 | High Volume, High Dose | Botox 150 units, prepared as 50 units/ml. Botox: Botox 75-150 units, single treatment only |
| FG002 | High Volume, Low Dose | Botox 75 units, prepared as 25 units/ml. Botox: Botox 75-150 units, single treatment only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Volume, High Dose | Botox, 150 units prepared as 100 units/ml Botox: Botox 75-150 units, single treatment only |
| BG001 | High Volume, High Dose | Botox 150 units, prepared as 50 units/ml. Botox: Botox 75-150 units, single treatment only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Posted | Mean | Full Range | score on a scale | Baseline |
|
Four months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Volume, High Dose | Botox, 150 units prepared as 100 units/ml Botox: Botox 75-150 units, single treatment only |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Change | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard E. Francisco | UTHealth | 7137975246 | Gerard.E.Francisco@uth.tmc.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001930 | Brain Injuries |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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
|
| 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
| Sixteen Weeks |
| 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). | 8 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| BG002 | Low Volume, Low Dose | Botox 75 units, prepared as 25 units/ml. Botox: Botox 75-150 units, single treatment only |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| High Volume, High Dose |
Botox 150 units, prepared as 50 units/ml. Botox: Botox 75-150 units, single treatment only |
| OG002 | High Volume, Low Dose | Botox 75 units, prepared as 25 units/ml. Botox: Botox 75-150 units, single treatment only |
|
|
| Primary | 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
| Posted | Mean | Full Range | score on a scale | Four weeks |
|
|
|
| Primary | 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
| Posted | Mean | Full Range | score on a scale | Eight Weeks |
|
|
|
| Primary | 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
| Data for this outcome measure were not collected for 2 in the Low volume High Dose arm, 1 in the High volume High Dose arm, and 1 in the High Volume Low Dose arm. | Posted | Mean | Full Range | score on a scale | Twelve Weeks |
|
|
|
| Primary | 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
| Data for this outcome measure were not collected for 1 in the High volume High Dose arm and 1 in the High Volume Low Dose arm. | Posted | Mean | Full Range | score on a scale | Sixteen Weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | degrees | Baseline |
|
|
|
| Secondary | 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). | Data were not collected for on in the Low volume, High Dose arm, one in the High volume, High Dose arm, and one in the High Volume, Low Dose arm. | Posted | Mean | Standard Deviation | degrees | 8 weeks |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | High Volume, High Dose | Botox 150 units, prepared as 50 units/ml. Botox: Botox 75-150 units, single treatment only | 0 | 9 | 2 | 9 |
| EG002 | Low Volume, Low Dose | Botox 75 units, prepared as 25 units/ml. Botox: Botox 75-150 units, single treatment only | 0 | 11 | 0 | 11 |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bowel urgency | Gastrointestinal disorders | Systematic Assessment |
|
| Increased Salivation | General disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|