Trial · NCT02145676
OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
NCT02145676, Phase 3, Terminated, Allergan; results first posted 2017-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity. Trials, record NCT02145676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02145676
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
- NCT number
- NCT02145676
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 53 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Muscle Spasticity, Stroke
- Interventions
- onabotulinumtoxinA, placebo (normal saline)
- First posted
- 2014-05-23
- Last updated
- 2017-04-12
- Other registries' IDs
- eudract:2013-002346-37
- Results first posted
- 2017-02-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | Baseline, Week 6 | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | Baseline, Week 6 | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Change From Baseline in Pain on an 11-Point Scale | Baseline, Week 6 | The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score \>0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | Baseline, Week 6 | The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions. |
| Secondary | Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | Baseline, Week 6 | The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question. |
| Secondary | Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | Baseline, Week 6 | The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain on an 11-Point Scale | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | onabotulinumtoxinA 500U | Baseline | 4.12 | Standard Deviation 0.332 | Scores on a Scale |
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | onabotulinumtoxinA 300U | Baseline | 4.06 | Standard Deviation 0.236 | Scores on a Scale |
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | Placebo (Normal Saline) | Baseline | 4.17 | Standard Deviation 0.383 | Scores on a Scale |
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | onabotulinumtoxinA 500U | Change from Baseline at Week 6 | -1.62 | Standard Deviation 1.455 | Scores on a Scale |
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | onabotulinumtoxinA 300U | Change from Baseline at Week 6 | -1.47 | Standard Deviation 1.247 | Scores on a Scale |
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | Placebo (Normal Saline) | Change from Baseline at Week 6 | -0.74 | Standard Deviation 0.970 | Scores on a Scale |
| Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | onabotulinumtoxinA 500U | Baseline | 4.00 | Standard Deviation 0.000 | Scores on a Scale |
| Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | onabotulinumtoxinA 300U | Baseline | 4.06 | Standard Deviation 0.236 | Scores on a Scale |
| Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | Placebo (Normal Saline) | Baseline | 4.00 | Standard Deviation 0.000 | Scores on a Scale |
| Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | onabotulinumtoxinA 500U | Change from Baseline at Week 6 | -1.59 | Standard Deviation 1.263 | Scores on a Scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | onabotulinumtoxinA 500U | 17 | |
| Overall Study | STARTED | onabotulinumtoxinA 300U | 18 | |
| Overall Study | STARTED | Placebo (Normal Saline) | 18 | |
| Overall Study | COMPLETED | onabotulinumtoxinA 500U | 17 | |
| Overall Study | COMPLETED | onabotulinumtoxinA 300U | 18 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) | 18 | |
| Overall Study | NOT COMPLETED | onabotulinumtoxinA 500U | 0 | |
| Overall Study | NOT COMPLETED | onabotulinumtoxinA 300U | 0 | |
| Overall Study | NOT COMPLETED | Placebo (Normal Saline) | 0 |
Source ClinicalTrials.gov
Adverse events87
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 |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | onabotulinumtoxinA 500U | 1 | 17 | |
| other | Bronchitis | Infections and infestations | onabotulinumtoxinA 300U | 1 | 18 | |
| other | Bronchitis | Infections and infestations | Placebo (Normal Saline) | 0 | 18 | |
| other | Seizure | Nervous system disorders | onabotulinumtoxinA 500U | 1 | 17 | |
| other | Seizure | Nervous system disorders | onabotulinumtoxinA 300U | 0 | 18 | |
| other | Seizure | Nervous system disorders | Placebo (Normal Saline) | 0 | 18 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | onabotulinumtoxinA 500U | 0 | 17 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | onabotulinumtoxinA 300U | 0 | 18 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Placebo (Normal Saline) | 1 | 18 | |
| other | Diarrhoea | Gastrointestinal disorders | onabotulinumtoxinA 500U | 1 | 17 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | onabotulinumtoxinA 500U | ||
| Total, all-cause mortality | onabotulinumtoxinA 300U | ||
| Total, all-cause mortality | Placebo (Normal Saline) | ||
| Total, other adverse events | onabotulinumtoxinA 500U | 4 | 17 |
| Total, other adverse events | onabotulinumtoxinA 300U | 5 | 18 |
| Total, other adverse events | Placebo (Normal Saline) | 7 | 18 |
| Total, serious adverse events | onabotulinumtoxinA 500U | 2 | 17 |
| Total, serious adverse events | onabotulinumtoxinA 300U | 0 | 18 |
| Total, serious adverse events | Placebo (Normal Saline) | 3 | 18 |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02145676
GET https://conductscience.org/api/trials/v1/NCT02145676/results?page=2