Trial Outcomes & Findings for Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity (NCT NCT00178646)
NCT ID: NCT00178646
Last Updated: 2021-01-22
Results Overview
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
COMPLETED
PHASE4
33 participants
Baseline
2021-01-22
Participant Flow
33 were enrolled but 32 started, and this is because one participant who enrolled decided not to start the study.
Participant milestones
| Measure |
Low Volume, High Dose
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
11
|
|
Overall Study
COMPLETED
|
12
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Volume, High Dose
n=12 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=9 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
Low Volume, Low Dose
n=11 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
9 Participants
n=9 Participants
|
11 Participants
n=11 Participants
|
32 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=11 Participants
|
9 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
5 Participants
n=9 Participants
|
8 Participants
n=11 Participants
|
23 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: BaselineThe 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
Outcome measures
| Measure |
Low Volume, High Dose
n=12 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=9 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=11 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Spastic Hypertonia as Measured by the Ashworth Scale
|
2.4 score on a scale
Interval 2.0 to 3.0
|
2.33 score on a scale
Interval 2.0 to 3.0
|
2.36 score on a scale
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Four weeksThe 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
Outcome measures
| Measure |
Low Volume, High Dose
n=12 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=9 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=11 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Spastic Hypertonia as Measured by the Ashworth Scale
|
2.42 score on a scale
Interval 2.0 to 3.0
|
2.56 score on a scale
Interval 2.0 to 3.0
|
2.36 score on a scale
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Eight WeeksThe 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
Outcome measures
| Measure |
Low Volume, High Dose
n=12 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=9 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=11 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Spastic Hypertonia as Measured by the Ashworth Scale
|
1.42 score on a scale
Interval 0.0 to 3.0
|
0.77 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Twelve WeeksPopulation: 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.
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
Outcome measures
| Measure |
Low Volume, High Dose
n=10 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=8 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=10 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Spastic Hypertonia as Measured by the Ashworth Scale
|
1.3 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
1.7 score on a scale
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Sixteen WeeksPopulation: 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.
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
Outcome measures
| Measure |
Low Volume, High Dose
n=12 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=8 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=10 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Spastic Hypertonia as Measured by the Ashworth Scale
|
1.42 score on a scale
Interval 0.0 to 2.0
|
1.13 score on a scale
Interval 1.0 to 2.0
|
1.1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: BaselineThis 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).
Outcome measures
| Measure |
Low Volume, High Dose
n=12 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=9 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=11 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Range of Motion as Measured by Goniometry
|
-9.42 degrees
Standard Deviation 5.42
|
-6.56 degrees
Standard Deviation 9.96
|
-19.64 degrees
Standard Deviation 13.90
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Low Volume, High Dose
n=11 Participants
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=8 Participants
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
High Volume, Low Dose
n=10 Participants
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Range of Motion as Measured by Goniometry
|
-1.82 degrees
Standard Deviation 6.82
|
2.25 degrees
Standard Deviation 8.08
|
-2.30 degrees
Standard Deviation 6.57
|
Adverse Events
Low Volume, High Dose
High Volume, High Dose
Low Volume, Low Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Volume, High Dose
n=12 participants at risk
Botox, 150 units prepared as 100 units/ml
Botox: Botox 75-150 units, single treatment only
|
High Volume, High Dose
n=9 participants at risk
Botox 150 units, prepared as 50 units/ml.
Botox: Botox 75-150 units, single treatment only
|
Low Volume, Low Dose
n=11 participants at risk
Botox 75 units, prepared as 25 units/ml.
Botox: Botox 75-150 units, single treatment only
|
|---|---|---|---|
|
Eye disorders
Visual Change
|
0.00%
0/12 • Four months
|
11.1%
1/9 • Number of events 1 • Four months
|
0.00%
0/11 • Four months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Four months
|
11.1%
1/9 • Number of events 1 • Four months
|
0.00%
0/11 • Four months
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/12 • Four months
|
11.1%
1/9 • Number of events 1 • Four months
|
0.00%
0/11 • Four months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
8.3%
1/12 • Number of events 1 • Four months
|
0.00%
0/9 • Four months
|
0.00%
0/11 • Four months
|
|
Gastrointestinal disorders
Bowel urgency
|
0.00%
0/12 • Four months
|
11.1%
1/9 • Number of events 1 • Four months
|
0.00%
0/11 • Four months
|
|
General disorders
Increased Salivation
|
0.00%
0/12 • Four months
|
11.1%
1/9 • Number of events 1 • Four months
|
0.00%
0/11 • Four months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place