Phase 2
Completed N=186
Dysport in Hallux Abducto Valgus (HAV) Phase IIa
Hallux Abducto Valgus
Source: ClinicalTrials.gov NCT03569098 ↗
Enrolled (actual)
186
Serious AEs
0.8%
Results posted
Jul 2021
Primary outcomePrimary: Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 — -2.04; -1.71; -2.40 units on a scale — p=0.7669
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 |
-2.04; -1.71; -2.40 | 0.7669 |
| SECONDARY LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 |
-1.68; -1.36; -1.85; -1.72; -1.61; -2.42 | — |
| SECONDARY LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 |
-17.95; -15.29; -16.87; -22.44; -18.68; -21.26 | — |
| SECONDARY LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 |
-17.97; -15.67; -19.30; -22.30; -20.69; -24.58 | — |
| SECONDARY LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 |
-14.87; -12.80; -15.10; -18.82; -16.16; -18.79 | — |
| SECONDARY LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 |
-9.02; -7.00; -9.03; -12.12; -8.81; -10.62 | — |
| SECONDARY LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 |
-0.31; -0.25; -0.92; -0.43; -0.67; -0.80 | — |
| SECONDARY LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 |
0.06; 0.40; 0.16; -0.02; 0.49; 0.45 | — |
| SECONDARY Median Time to Retreatment |
12.6; 13.1; 13.1 | — |
| SECONDARY LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 |
-0.76; -0.56; -0.46; -0.74; -0.64; -0.79 | — |
| SECONDARY LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 |
-0.47; -0.57; -0.42; -0.54; -0.66; -0.68 | — |
| SECONDARY LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 |
1.32; 1.32; 1.53; 1.30; 1.36; 1.32 | — |
| SECONDARY LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 |
1.15; 1.16; 1.31; 1.19; 1.23; 1.41 | — |
| SECONDARY Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 |
3.08; 3.19; 3.30; 3.19; 5.04; 2.51 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03569098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.