18 and older, any sex, with Hallux Abducto Valgus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8Primary· 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 d
Group
Value
95% CI
Placebo
-2.04
-2.66 – -1.41
Dysport 300 U
-1.71
-2.33 – -1.10
Dysport 500 U
-2.40
-3.03 – -1.77
LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12Secondary· 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 Ba
Week 4
Group
Value
95% CI
Placebo
-1.68
-2.26 – -1.11
Dysport 300 U
-1.36
-1.94 – -0.78
Dysport 500 U
-1.85
-2.45 – -1.25
Week 12
Group
Value
95% CI
Placebo
-1.72
-2.35 – -1.09
Dysport 300 U
-1.61
-2.23 – -1.00
Dysport 500 U
-2.42
-3.06 – -1.78
LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12Secondary· 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 t
Week 4
Group
Value
95% CI
Placebo
-17.95
-23.06 – -12.84
Dysport 300 U
-15.29
-20.47 – -10.12
Dysport 500 U
-16.87
-22.27 – -11.48
Week 8
Group
Value
95% CI
Placebo
-22.44
-28.00 – -16.87
Dysport 300 U
-18.68
-24.19 – -13.17
Dysport 500 U
-21.26
-27.05 – -15.48
Week 12
Group
Value
95% CI
Placebo
-17.21
-23.11 – -11.31
Dysport 300 U
-21.04
-26.80 – -15.27
Dysport 500 U
-21.50
-27.61 – -15.39
LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12Secondary· 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 be
Week 4
Group
Value
95% CI
Placebo
-17.97
-23.23 – -12.70
Dysport 300 U
-15.67
-21.00 – -10.33
Dysport 500 U
-19.30
-24.86 – -13.73
Week 8
Group
Value
95% CI
Placebo
-22.30
-28.15 – -16.45
Dysport 300 U
-20.69
-26.50 – -14.88
Dysport 500 U
-24.58
-30.67 – -18.49
Week 12
Group
Value
95% CI
Placebo
-18.94
-25.05 – -12.83
Dysport 300 U
-21.74
-27.72 – -15.76
Dysport 500 U
-24.30
-30.64 – -17.96
LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12Secondary· 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 pa
Week 4
Group
Value
95% CI
Placebo
-14.87
-18.98 – -10.75
Dysport 300 U
-12.80
-16.96 – -8.64
Dysport 500 U
-15.10
-19.45 – -10.76
Week 8
Group
Value
95% CI
Placebo
-18.82
-23.32 – -14.32
Dysport 300 U
-16.16
-20.62 – -11.69
Dysport 500 U
-18.79
-23.48 – -14.11
Week 12
Group
Value
95% CI
Placebo
-15.65
-20.48 – -10.82
Dysport 300 U
-17.45
-22.18 – -12.72
Dysport 500 U
-18.89
-23.90 – -13.88
LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12Secondary· 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 num
Week 4
Group
Value
95% CI
Placebo
-9.02
-12.08 – -5.96
Dysport 300 U
-7.00
-10.08 – -3.91
Dysport 500 U
-9.03
-12.28 – -5.79
Week 8
Group
Value
95% CI
Placebo
-12.12
-15.52 – -8.71
Dysport 300 U
-8.81
-12.17 – -5.45
Dysport 500 U
-10.62
-14.17 – -7.07
Week 12
Group
Value
95% CI
Placebo
-11.09
-14.79 – -7.40
Dysport 300 U
-9.25
-12.87 – -5.63
Dysport 500 U
-10.84
-14.69 – -6.99
LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12Secondary· 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).
Week 4
Group
Value
95% CI
Placebo
-0.31
-1.06 – 0.45
Dysport 300 U
-0.25
-0.99 – 0.49
Dysport 500 U
-0.92
-1.71 – -0.13
Week 8
Group
Value
95% CI
Placebo
-0.43
-1.17 – 0.30
Dysport 300 U
-0.67
-1.40 – 0.05
Dysport 500 U
-0.80
-1.57 – -0.04
Week 12
Group
Value
95% CI
Placebo
0.30
-0.44 – 1.05
Dysport 300 U
-0.68
-1.41 – 0.04
Dysport 500 U
-0.45
-1.22 – 0.33
LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12Secondary· 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.
Week 4
Group
Value
95% CI
Placebo
0.06
-0.34 – 0.46
Dysport 300 U
0.40
0.01 – 0.79
Dysport 500 U
0.16
-0.25 – 0.58
Week 8
Group
Value
95% CI
Placebo
-0.02
-0.41 – 0.36
Dysport 300 U
0.49
0.11 – 0.87
Dysport 500 U
0.45
0.05 – 0.85
Week 12
Group
Value
95% CI
Placebo
0.42
0.01 – 0.83
Dysport 300 U
0.19
-0.21 – 0.59
Dysport 500 U
0.04
-0.38 – 0.47
Median Time to RetreatmentSecondary· 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.
Group
Value
95% CI
Placebo
12.6
12 – 13
Dysport 300 U
13.1
13 – 16
Dysport 500 U
13.1
13 – 15
LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12Secondary· 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).
Week 4
Group
Value
95% CI
Placebo
-0.76
-0.99 – -0.54
Dysport 300 U
-0.56
-0.80 – -0.32
Dysport 500 U
-0.46
-0.71 – -0.22
Week 8
Group
Value
95% CI
Placebo
-0.74
-0.97 – -0.51
Dysport 300 U
-0.64
-0.88 – -0.39
Dysport 500 U
-0.79
-1.03 – -0.56
Week 12
Group
Value
95% CI
Placebo
-0.58
-0.82 – -0.35
Dysport 300 U
-0.59
-0.82 – -0.36
Dysport 500 U
-0.60
-0.85 – -0.35
LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12Secondary· 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).
Week 4
Group
Value
95% CI
Placebo
-0.47
-0.70 – -0.25
Dysport 300 U
-0.57
-0.82 – -0.32
Dysport 500 U
-0.42
-0.68 – -0.16
Week 8
Group
Value
95% CI
Placebo
-0.54
-0.80 – -0.28
Dysport 300 U
-0.66
-0.93 – -0.38
Dysport 500 U
-0.68
-0.94 – -0.42
Week 12
Group
Value
95% CI
Placebo
-0.55
-0.80 – -0.31
Dysport 300 U
-0.63
-0.87 – -0.38
Dysport 500 U
-0.67
-0.93 – -0.40
LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12Secondary· 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".
Week 4
Group
Value
95% CI
Placebo
1.32
0.98 – 1.65
Dysport 300 U
1.32
0.98 – 1.66
Dysport 500 U
1.53
1.17 – 1.90
Week 8
Group
Value
95% CI
Placebo
1.30
0.94 – 1.67
Dysport 300 U
1.36
1.00 – 1.73
Dysport 500 U
1.32
0.96 – 1.69
Week 12
Group
Value
95% CI
Placebo
1.28
0.93 – 1.63
Dysport 300 U
1.40
1.07 – 1.74
Dysport 500 U
1.21
0.83 – 1.59
Adverse events — posted to ClinicalTrials.gov
Time frame: From first administration of study drug (Cycle 1 Day 1) up to end of the study, approximately 36 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Double-Blind Treatment Period (Cycle 1): Placebo
Serious: 0/61 (0%)
Deaths: 0/61
Double-Blind Treatment Period (Cycle 1): Dysport 300 U
Serious: 0/63 (0%)
Deaths: 0/63
Double-Blind Treatment Period (Cycle 1): Dysport 500 U
Serious: 1/56 (2%)
Deaths: 0/56
Open-Label Treatment Period (Cycle 2): Dysport 300 U
Serious: 1/146 (1%)
Deaths: 0/146
Open-Label Treatment Period (Cycle 3): Dysport 300 U
Serious: 0/8 (0%)
Deaths: 0/8
Open-Label Treatment Period (Cycle 3): Dysport 500 U
Serious: 1/56 (2%)
Deaths: 0/56
Serious adverse events (5 terms)
Reaction
System
Double-Blind Treatment Per…
Double-Blind Treatment Per…
Double-Blind Treatment Per…
Open-Label Treatment Perio…
Open-Label Treatment Perio…
Open-Label Treatment Perio…
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ipsen
Last refreshed: 2 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03569098.