Trial · NCT01387074
Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
NCT01387074, Completed, Allergan; results first posted 2014-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity. Trials, record NCT01387074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387074
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
- NCT number
- NCT01387074
- Status
- Completed
- Enrollment
- 108 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Muscle Spasticity
- Interventions
- botulinum toxin Type A
- First posted
- 2011-07-04
- Last updated
- 2014-02-03
- Results first posted
- 2014-02-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Baseline | The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Week 24 | The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | Baseline | The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | Week 24 | The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | Baseline | The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | Week 24 | The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | Baseline | The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
| Primary | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | Week 24 | The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Baseline | Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Week 24 | Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | Baseline | Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | Week 24 | Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | Baseline | Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | Week 24 | Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | Baseline | Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin. | Participants | NUMBER |
| PRIMARY | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | Week 24 | Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Botulinum Toxin Type A | 0=No Increase | 2 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Botulinum Toxin Type A | 1=Slight Increase | 6 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Botulinum Toxin Type A | 1+=Slight Increase | 18 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Botulinum Toxin Type A | 2=Marked Increase | 39 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Botulinum Toxin Type A | 3=Considerable Increase | 30 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Botulinum Toxin Type A | 4=Affected part rigid | 6 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Botulinum Toxin Type A | 0=No Increase | 2 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Botulinum Toxin Type A | 1=Slight Increase | 26 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Botulinum Toxin Type A | 1+=Slight Increase | 43 | Participants | |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Botulinum Toxin Type A | 2=Marked Increase | 12 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Type A | 108 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A | 100 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A | 8 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Status epilepticus | Nervous system disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Bacteraemia | Infections and infestations | Botulinum Toxin Type A | 1 | 108 | |
| serious | Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Gastroenteritis norovirus | Gastrointestinal disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Clostridium difficile colitis | Infections and infestations | Botulinum Toxin Type A | 1 | 108 | |
| serious | Hypokalaemia | Metabolism and nutrition disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Type 2 diabetes mellitus | Endocrine disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Hypoglycaemia | Endocrine disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Candiduria | Renal and urinary disorders | Botulinum Toxin Type A | 1 | 108 | |
| serious | Dehydration | Metabolism and nutrition disorders | Botulinum Toxin Type A | 1 | 108 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A | ||
| Total, other adverse events | Botulinum Toxin Type A | 0 | 108 |
| Total, serious adverse events | Botulinum Toxin Type A | 1 | 108 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01387074
GET https://conductscience.org/api/trials/v1/NCT01387074/results?page=2