Hallux Abducto Valgus
Conditions
Brief summary
The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.
Interventions
BIOLOGICALBotulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
DRUGPlacebo
Investigators will inject the reconstituted solution into foot muscles.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of HAV * Painful HAV in the study foot at Baseline
Exclusion criteria
* Flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in the study foot * Other podiatric or orthopedic condition which would interfere with the evaluation of pain and/or function * Medical history or clinical evidence of any vascular disease and/or diabetic condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 | Baseline and Week 8 in the double-blind treatment period | The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents no pain and 10 represents worst possible pain. Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an electronic diary (eDiary) for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | The HV angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 centimeters (cm). |
| LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | The intermetatarsal angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 cm. |
| Median Time to Retreatment | Up to 24 weeks in the double-blind treatment period | Time to retreatment was calculated as (\[Date of retreatment - previous injection date\] + 1) / 7 (week). Time to retreatment was calculated for each cycle and the data presented here for the double-blind treatment period. |
| LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | An assessment of PGI-S of foot pain was conducted by the participant using a 4-point Likert scale ranging from 0= no pain to 3= severe pain. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: How severe was your foot pain while performing physical activities (example, standing, walking or running) over the past week? (0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain). |
| LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | An assessment of PGI-S of disability was conducted by the participant using a 4-point Likert scale ranging from 0= no disability to 3= severe disability. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: How severe was your disability while performing physical activities (example, standing, walking or running) over the past week? (0=no disability; 1=mild disability; 2=moderate disability; 3=severe disability). |
| LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 in the double-blind treatment period | An assessment of PGI-I of foot pain was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: Compared to your foot pain prior to the study treatment initiation, your foot pain while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse. |
| LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI activity limitation subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents none of the time and 10 represents all of the time. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome. |
| LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Baseline and Weeks 4 and 12 in the double-blind treatment period | The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents no pain and 10 represents worst possible pain. Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an eDiary for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1). |
| LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | The foot function index (FFI) was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI disability subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents no difficulty and 10 represents so difficult unable to do. For each item, the participant was asked to record the number value which best corresponded to effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome. |
| LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI pain subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents no pain and 10 represents worst pain imaginable. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome. |
| LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 in the double-blind treatment period | The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into three subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI items are rated using numeric rating scales ranging from 0 to 10, where 0 represents no pain/no difficulty/none of the time and 10 represents worst pain imaginable/so difficult unable to do/all of the time for pain, disability and activity limitation subscales, respectively. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a total score, the scores of all 3 subscales were totaled and divided by 3. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome. |
| Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Baseline and Weeks 8 and 12 in the double-blind treatment period | The SF-36 is a 36-item questionnaire which measures the extent to which physical health impacts an individual's functional ability and perceived wellbeing in mental, social, and physical aspects of life. The SF-36 has 8 subscales: physical function, role physical, bodily pain, global health, vitality, social function, role emotional and mental health. Each scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Scores on these subscales can be aggregated into the physical component summary (physical function, role physical, bodily pain and global health) and mental component summary (mental health, vitality, social function and role emotional). Physical component summary score ranges from 0.65 to 80.73 and mental component summary score ranges from -8.81 to 81.65, where low score indicates lowest level of health and high score indicates highest level of health. Positive change from Baseline indicates an improvement in quality of life. |
| LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 in the double-blind treatment period | An assessment of PGI-I of the participant's disability was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: Compared to your disability prior to the study treatment initiation, your disability while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse. |
Countries
United States
Participant flow
Recruitment details
This Phase II double-blind study was conducted at 27 sites in the United States between 19 June 2018 and 22 May 2020 in adult participants suffering from clinically significant hallux abducto valgus (HV) who have not undergone surgery for their condition.
Pre-assignment details
The study consisted of a screening period (up to 3 weeks), followed by a double-blind treatment period (Cycle 1). From Week 12, retreatment criteria were evaluated every 4 weeks to determine eligibility to receive treatment in the open-label period (Cycles 2 and 3). Total study duration was a maximum of 36 weeks. A total of 186 participants were randomized in a 1:1:1 ratio to 1 of 3 treatment groups (placebo, Dysport 300 units (U) and Dysport 500 U) in the double-blind treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of placebo (matching with Dysport) intramuscular injection distributed between 4 injection points in the 4 targeted muscles of the study foot.
Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.
The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle. | 63 |
| Dysport 300 U On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.
Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.
The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle. | 63 |
| Dysport 500 U On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.
Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.
The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle. | 60 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind Treatment Cycle 1 | Lost to Follow-up | 1 | 1 | 0 |
| Double-Blind Treatment Cycle 1 | Other | 1 | 0 | 1 |
| Double-Blind Treatment Cycle 1 | Physician Decision | 1 | 0 | 0 |
| Double-Blind Treatment Cycle 1 | Protocol deviation | 0 | 1 | 0 |
| Double-Blind Treatment Cycle 1 | Study terminated by sponsor | 0 | 6 | 3 |
| Double-Blind Treatment Cycle 1 | Technical problems | 0 | 0 | 2 |
| Double-Blind Treatment Cycle 1 | Withdrawal by Subject | 5 | 2 | 5 |
| Open-Label Treatment Cycle 2 | Lost to Follow-up | 0 | 3 | 0 |
| Open-Label Treatment Cycle 2 | Study terminated by sponsor | 0 | 21 | 0 |
| Open-Label Treatment Cycle 2 | Withdrawal by Subject | 0 | 11 | 0 |
| Open-Label Treatment Cycle 3 | Lost to Follow-up | 0 | 0 | 1 |
| Open-Label Treatment Cycle 3 | Study terminated by sponsor | 0 | 1 | 1 |
| Open-Label Treatment Cycle 3 | Withdrawal by Subject | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Placebo | Dysport 300 U | Dysport 500 U | Total |
|---|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 13.18 | 48.4 years STANDARD_DEVIATION 14.04 | 48.0 years STANDARD_DEVIATION 12.24 | 48.2 years STANDARD_DEVIATION 13.12 |
| Age, Customized >=65 and <85 years | 7 Participants | 5 Participants | 3 Participants | 15 Participants |
| Age, Customized <65 years | 56 Participants | 58 Participants | 57 Participants | 171 Participants |
| Age, Customized >=85 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 5 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized Black or African American | 10 participants | 4 participants | 9 participants | 23 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 16 participants | 10 participants | 16 participants | 42 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 47 participants | 53 participants | 44 participants | 144 participants |
| Race/Ethnicity, Customized Other | 3 participants | 0 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized White | 49 participants | 54 participants | 43 participants | 146 participants |
| Sex: Female, Male Female | 55 Participants | 60 Participants | 56 Participants | 171 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 63 | 0 / 56 | 0 / 146 | 0 / 8 | 0 / 56 |
| other Total, other adverse events | 6 / 61 | 9 / 63 | 6 / 56 | 11 / 146 | 0 / 8 | 4 / 56 |
| serious Total, serious adverse events | 0 / 61 | 0 / 63 | 1 / 56 | 1 / 146 | 0 / 8 | 1 / 56 |
Outcome results
Primary
Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents no pain and 10 represents worst possible pain. Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an electronic diary (eDiary) for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1).
Time frame: Baseline and Week 8 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. For participants without any available post-Baseline NPRS average scores, the Week 8 average pain score was imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 | -2.04 units on a scale |
| Dysport 300 U | Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 | -1.71 units on a scale |
| Dysport 500 U | Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 | -2.40 units on a scale |
Comparison: Dysport 300 U versus Placebo.p-value: 0.766995% CI: [-0.55, 1.19]Mixed Model for Repeated Measures (MMRM)
Comparison: Dysport 500 U versus Placebo.p-value: 0.208595% CI: [-1.24, 0.51]MMRM
Secondary
LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12
The HV angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 centimeters (cm).
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 8 | -0.43 degrees |
| Placebo | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 4 | -0.31 degrees |
| Placebo | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 12 | 0.30 degrees |
| Dysport 300 U | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 8 | -0.67 degrees |
| Dysport 300 U | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 4 | -0.25 degrees |
| Dysport 300 U | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 12 | -0.68 degrees |
| Dysport 500 U | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 4 | -0.92 degrees |
| Dysport 500 U | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 12 | -0.45 degrees |
| Dysport 500 U | LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 | Week 8 | -0.80 degrees |
Secondary
LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12
The intermetatarsal angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 cm.
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 8 | -0.02 degrees |
| Placebo | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 4 | 0.06 degrees |
| Placebo | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 12 | 0.42 degrees |
| Dysport 300 U | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 8 | 0.49 degrees |
| Dysport 300 U | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 4 | 0.40 degrees |
| Dysport 300 U | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 12 | 0.19 degrees |
| Dysport 500 U | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 4 | 0.16 degrees |
| Dysport 500 U | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 12 | 0.04 degrees |
| Dysport 500 U | LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 | Week 8 | 0.45 degrees |
Secondary
LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12
An assessment of PGI-S of foot pain was conducted by the participant using a 4-point Likert scale ranging from 0= no pain to 3= severe pain. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: How severe was your foot pain while performing physical activities (example, standing, walking or running) over the past week? (0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain).
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 8 | -0.74 units on a scale |
| Placebo | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 4 | -0.76 units on a scale |
| Placebo | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 12 | -0.58 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 8 | -0.64 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 4 | -0.56 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 12 | -0.59 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 4 | -0.46 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 12 | -0.60 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 | Week 8 | -0.79 units on a scale |
Secondary
LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12
An assessment of PGI-S of disability was conducted by the participant using a 4-point Likert scale ranging from 0= no disability to 3= severe disability. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: How severe was your disability while performing physical activities (example, standing, walking or running) over the past week? (0=no disability; 1=mild disability; 2=moderate disability; 3=severe disability).
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 8 | -0.54 units on a scale |
| Placebo | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 4 | -0.47 units on a scale |
| Placebo | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 12 | -0.55 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 8 | -0.66 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 4 | -0.57 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 12 | -0.63 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 4 | -0.42 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 12 | -0.67 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 | Week 8 | -0.68 units on a scale |
Secondary
LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12
The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI activity limitation subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents none of the time and 10 represents all of the time. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 12 | -11.09 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 4 | -9.02 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 8 | -12.12 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 8 | -8.81 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 12 | -9.25 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 4 | -7.00 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 4 | -9.03 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 12 | -10.84 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 | Week 8 | -10.62 units on a scale |
Secondary
LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12
The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI pain subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents no pain and 10 represents worst pain imaginable. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 8 | -22.30 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 4 | -17.97 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 12 | -18.94 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 8 | -20.69 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 4 | -15.67 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 12 | -21.74 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 4 | -19.30 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 12 | -24.30 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 | Week 8 | -24.58 units on a scale |
Secondary
LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12
The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into three subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI items are rated using numeric rating scales ranging from 0 to 10, where 0 represents no pain/no difficulty/none of the time and 10 represents worst pain imaginable/so difficult unable to do/all of the time for pain, disability and activity limitation subscales, respectively. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a total score, the scores of all 3 subscales were totaled and divided by 3. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 8 | -18.82 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 4 | -14.87 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 12 | -15.65 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 8 | -16.16 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 4 | -12.80 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 12 | -17.45 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 4 | -15.10 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 12 | -18.89 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 | Week 8 | -18.79 units on a scale |
Secondary
LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12
The foot function index (FFI) was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI disability subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents no difficulty and 10 represents so difficult unable to do. For each item, the participant was asked to record the number value which best corresponded to effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
Time frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 8 | -22.44 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 4 | -17.95 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 12 | -17.21 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 8 | -18.68 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 4 | -15.29 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 12 | -21.04 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 4 | -16.87 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 12 | -21.50 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 | Week 8 | -21.26 units on a scale |
Secondary
LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12
The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents no pain and 10 represents worst possible pain. Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an eDiary for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1).
Time frame: Baseline and Weeks 4 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. For participants without any available post-Baseline NPRS average scores, the Weeks 4 and 12 average pain scores were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Week 4 | -1.68 units on a scale |
| Placebo | LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Week 12 | -1.72 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Week 4 | -1.36 units on a scale |
| Dysport 300 U | LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Week 12 | -1.61 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Week 4 | -1.85 units on a scale |
| Dysport 500 U | LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 | Week 12 | -2.42 units on a scale |
Secondary
LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12
An assessment of PGI-I of foot pain was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: Compared to your foot pain prior to the study treatment initiation, your foot pain while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse.
Time frame: Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 8 | 1.30 units on a scale |
| Placebo | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 4 | 1.32 units on a scale |
| Placebo | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 12 | 1.28 units on a scale |
| Dysport 300 U | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 8 | 1.36 units on a scale |
| Dysport 300 U | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 4 | 1.32 units on a scale |
| Dysport 300 U | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 12 | 1.40 units on a scale |
| Dysport 500 U | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 4 | 1.53 units on a scale |
| Dysport 500 U | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 12 | 1.21 units on a scale |
| Dysport 500 U | LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 | Week 8 | 1.32 units on a scale |
Secondary
LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12
An assessment of PGI-I of the participant's disability was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: Compared to your disability prior to the study treatment initiation, your disability while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse.
Time frame: Weeks 4, 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at specific time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 8 | 1.19 units on a scale |
| Placebo | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 4 | 1.15 units on a scale |
| Placebo | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 12 | 1.15 units on a scale |
| Dysport 300 U | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 8 | 1.23 units on a scale |
| Dysport 300 U | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 4 | 1.16 units on a scale |
| Dysport 300 U | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 12 | 1.21 units on a scale |
| Dysport 500 U | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 4 | 1.31 units on a scale |
| Dysport 500 U | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 12 | 1.28 units on a scale |
| Dysport 500 U | LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 | Week 8 | 1.41 units on a scale |
Secondary
Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12
The SF-36 is a 36-item questionnaire which measures the extent to which physical health impacts an individual's functional ability and perceived wellbeing in mental, social, and physical aspects of life. The SF-36 has 8 subscales: physical function, role physical, bodily pain, global health, vitality, social function, role emotional and mental health. Each scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Scores on these subscales can be aggregated into the physical component summary (physical function, role physical, bodily pain and global health) and mental component summary (mental health, vitality, social function and role emotional). Physical component summary score ranges from 0.65 to 80.73 and mental component summary score ranges from -8.81 to 81.65, where low score indicates lowest level of health and high score indicates highest level of health. Positive change from Baseline indicates an improvement in quality of life.
Time frame: Baseline and Weeks 8 and 12 in the double-blind treatment period
Population: The ITT analysis set included all randomized participants. The results are presented for the participants with data available at Baseline and specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 8: SF-36 - Physical component summary score | 3.08 units on a scale | Standard Deviation 7.815 |
| Placebo | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 12: SF-36 - Physical component summary score | 3.19 units on a scale | Standard Deviation 7.776 |
| Placebo | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 8: SF-36 - Mental component summary score | -0.66 units on a scale | Standard Deviation 7.299 |
| Placebo | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 12: SF-36 - Mental component summary score | -0.43 units on a scale | Standard Deviation 5.587 |
| Dysport 300 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 12: SF-36 - Mental component summary score | -0.28 units on a scale | Standard Deviation 7.821 |
| Dysport 300 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 8: SF-36 - Physical component summary score | 3.19 units on a scale | Standard Deviation 6.013 |
| Dysport 300 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 8: SF-36 - Mental component summary score | -0.30 units on a scale | Standard Deviation 6.419 |
| Dysport 300 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 12: SF-36 - Physical component summary score | 5.04 units on a scale | Standard Deviation 7.43 |
| Dysport 500 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 12: SF-36 - Mental component summary score | -0.22 units on a scale | Standard Deviation 6.97 |
| Dysport 500 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 12: SF-36 - Physical component summary score | 2.51 units on a scale | Standard Deviation 7.133 |
| Dysport 500 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 8: SF-36 - Mental component summary score | -0.84 units on a scale | Standard Deviation 6.022 |
| Dysport 500 U | Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 | Week 8: SF-36 - Physical component summary score | 3.30 units on a scale | Standard Deviation 7.127 |
Secondary
Median Time to Retreatment
Time to retreatment was calculated as (\[Date of retreatment - previous injection date\] + 1) / 7 (week). Time to retreatment was calculated for each cycle and the data presented here for the double-blind treatment period.
Time frame: Up to 24 weeks in the double-blind treatment period
Population: The safety population included all participants who received at least one dose of study drug administration (including only partial administration). Participants who were not retreated were considered censored at the date of their last visit and not included in the summary but included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Time to Retreatment | 12.6 weeks |
| Dysport 300 U | Median Time to Retreatment | 13.1 weeks |
| Dysport 500 U | Median Time to Retreatment | 13.1 weeks |