Osteoarthritis
Conditions
Brief summary
This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.
Interventions
BIOLOGICALonabotulinumtoxinA
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
DRUGNormal Saline
Normal Saline (placebo) injection into the intra-articular space of the study knee.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Painful osteoarthritis * Able to discontinue anti-inflammatory drugs and analgesics * Must be ambulatory without assistive walking devices
Exclusion criteria
* Chronic pain conditions other than knee osteoarthritis * Treatment with corticosteroids in the study knee within 12 weeks * Treatment with hyaluronic acid in the study knee within 24 weeks * Previous treatment with any botulinum toxin for any reason * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Baseline, Week 8 | Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 | The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement. |
| Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 | The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement. |
| Patient Global Impression of Change (GIC) Using a 7-Point Scale | Weeks 1, 4, 8, 12, 16, 20 and 24 | The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement. |
| Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Baseline, Week 24 | Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement. |
Countries
Czechia, Denmark, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OnabotulinumtoxinA 400 U OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. | 44 |
| OnabotulinumtoxinA 200 U OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. | 43 |
| Placebo Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1. | 89 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Other Miscellaneous Reason | 0 | 1 | 2 |
| Overall Study | Personal Reasons | 2 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | OnabotulinumtoxinA 400 U | OnabotulinumtoxinA 200 U | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 8.25 | 60.2 years STANDARD_DEVIATION 8.41 | 61.1 years STANDARD_DEVIATION 7.79 | 60.8 years STANDARD_DEVIATION 8.02 |
| Sex: Female, Male Female | 30 Participants | 26 Participants | 51 Participants | 107 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 38 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 44 | 15 / 43 | 26 / 89 |
| serious Total, serious adverse events | 6 / 44 | 4 / 43 | 6 / 89 |
Outcome results
Primary
Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 8
Population: Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA 400 U | Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Baseline | 5.92 score on a scale | Standard Deviation 1.222 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.68 score on a scale | Standard Deviation 1.641 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Baseline | 6.09 score on a scale | Standard Deviation 1.313 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Change from Baseline at Week 8 | -2.07 score on a scale | Standard Deviation 1.602 |
| Placebo | Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Baseline | 6.00 score on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.98 score on a scale | Standard Deviation 1.793 |
Secondary
Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 24
Population: Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA 400 U | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Baseline | 6.50 score on a scale | Standard Deviation 1.243 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Week 24 | -1.48 score on a scale | Standard Deviation 1.894 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Baseline | 6.84 score on a scale | Standard Deviation 1.342 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Week 24 | -2.07 score on a scale | Standard Deviation 2.126 |
| Placebo | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Baseline | 6.63 score on a scale | Standard Deviation 1.157 |
| Placebo | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Week 24 | -1.80 score on a scale | Standard Deviation 1.896 |
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Population: Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Baseline | 5.84 score on a scale | Standard Deviation 1.629 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 1 | -1.75 score on a scale | Standard Deviation 1.567 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 4 | -1.82 score on a scale | Standard Deviation 1.893 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 8 | -2.02 score on a scale | Standard Deviation 1.899 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 12 | -1.81 score on a scale | Standard Deviation 1.975 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 16 | -1.67 score on a scale | Standard Deviation 1.841 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 20 | -1.79 score on a scale | Standard Deviation 1.937 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 24 | -1.93 score on a scale | Standard Deviation 2.289 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 4 | -1.67 score on a scale | Standard Deviation 1.763 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 20 | -1.68 score on a scale | Standard Deviation 2.066 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.52 score on a scale | Standard Deviation 1.907 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 12 | -1.82 score on a scale | Standard Deviation 1.87 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 16 | -1.64 score on a scale | Standard Deviation 2.174 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Baseline | 5.41 score on a scale | Standard Deviation 1.806 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 1 | -1.61 score on a scale | Standard Deviation 1.666 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 24 | -1.81 score on a scale | Standard Deviation 2.181 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 4 | -1.81 score on a scale | Standard Deviation 1.848 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 1 | -1.62 score on a scale | Standard Deviation 1.805 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Baseline | 5.34 score on a scale | Standard Deviation 1.548 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.76 score on a scale | Standard Deviation 1.976 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 20 | -1.78 score on a scale | Standard Deviation 2.037 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 16 | -1.62 score on a scale | Standard Deviation 1.901 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 12 | -1.75 score on a scale | Standard Deviation 2.014 |
| Placebo | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | Change from Baseline at Week 24 | -1.69 score on a scale | Standard Deviation 2.008 |
Secondary
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Population: Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Baseline | 5.56 score on a scale | Standard Deviation 1.804 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 1 | -1.33 score on a scale | Standard Deviation 1.424 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 4 | -1.26 score on a scale | Standard Deviation 1.672 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.54 score on a scale | Standard Deviation 1.819 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 12 | -1.30 score on a scale | Standard Deviation 1.648 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 16 | -1.29 score on a scale | Standard Deviation 1.558 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 20 | -1.34 score on a scale | Standard Deviation 1.651 |
| OnabotulinumtoxinA 400 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 24 | -1.48 score on a scale | Standard Deviation 2.029 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 4 | -1.66 score on a scale | Standard Deviation 1.908 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 20 | -1.44 score on a scale | Standard Deviation 2.172 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.50 score on a scale | Standard Deviation 2.043 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 12 | -1.68 score on a scale | Standard Deviation 1.781 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 16 | -1.59 score on a scale | Standard Deviation 2.127 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Baseline | 5.35 score on a scale | Standard Deviation 1.995 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 1 | -1.64 score on a scale | Standard Deviation 1.87 |
| OnabotulinumtoxinA 200 U | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 24 | -1.56 score on a scale | Standard Deviation 2.232 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 4 | -1.35 score on a scale | Standard Deviation 2.069 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 1 | -1.44 score on a scale | Standard Deviation 1.933 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Baseline | 4.99 score on a scale | Standard Deviation 1.854 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 8 | -1.27 score on a scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 20 | -1.18 score on a scale | Standard Deviation 2.087 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 16 | -1.09 score on a scale | Standard Deviation 1.991 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 12 | -1.40 score on a scale | Standard Deviation 2.17 |
| Placebo | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | Change from Baseline at Week 24 | -1.12 score on a scale | Standard Deviation 1.998 |
Secondary
Patient Global Impression of Change (GIC) Using a 7-Point Scale
The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.
Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24
Population: Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 24 | 0.8 score on a scale | Standard Deviation 1.34 |
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 16 | 1.1 score on a scale | Standard Deviation 1.31 |
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 12 | 1.1 score on a scale | Standard Deviation 1.35 |
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 4 | 0.9 score on a scale | Standard Deviation 1.24 |
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 1 | 0.9 score on a scale | Standard Deviation 1 |
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 20 | 1.1 score on a scale | Standard Deviation 1.24 |
| OnabotulinumtoxinA 400 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 8 | 1.1 score on a scale | Standard Deviation 1.09 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 12 | 1.2 score on a scale | Standard Deviation 1.3 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 1 | 1.2 score on a scale | Standard Deviation 0.97 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 4 | 1.2 score on a scale | Standard Deviation 1.23 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 8 | 0.9 score on a scale | Standard Deviation 1.35 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 16 | 1.1 score on a scale | Standard Deviation 1.36 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 20 | 1.0 score on a scale | Standard Deviation 1.42 |
| OnabotulinumtoxinA 200 U | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 24 | 1.0 score on a scale | Standard Deviation 1.41 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 16 | 1.0 score on a scale | Standard Deviation 1.1 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 4 | 1.2 score on a scale | Standard Deviation 1.1 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 24 | 0.9 score on a scale | Standard Deviation 1.28 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 20 | 1.0 score on a scale | Standard Deviation 1.2 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 12 | 1.0 score on a scale | Standard Deviation 1.14 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 8 | 1.0 score on a scale | Standard Deviation 1 |
| Placebo | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Week 1 | 1.1 score on a scale | Standard Deviation 1.09 |