Phase 2 N=186 Randomized Double-blind Treatment

Dysport in Hallux Abducto Valgus (HAV) Phase IIa

Hallux Abducto Valgus

Bottom Line

View on ClinicalTrials.gov: NCT03569098 ↗

Enrolled (actual)

186

Serious AEs

0.8%

Results posted

Jul 2021

Primary outcome: 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 units on a scale — p=0.7669

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Botulinum toxin type A (Biological); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Dec 2019

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	—

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.

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

View full record on ClinicalTrials.gov →

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.