A Multiple-dose, Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dysport for the Treatment of Pain Associated With Hallux Abducto Valgus
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Hallux Abducto Valgus
- Sponsor
- Ipsen
- Enrollment
- 186
- Locations
- 29
- Primary Endpoint
- Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
Placebo
Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
Intervention: Placebo
Dysport Dose 1
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
Intervention: Botulinum toxin type A
Dysport Dose 2
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
Intervention: Botulinum toxin type A
Outcomes
Primary Outcomes
Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- Median Time to Retreatment(Up to 24 weeks in 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12(Weeks 4, 8 and 12 in the double-blind treatment period)
- 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)