Clinical trial NCT03569098: Dysport in Hallux Abducto Valgus (HAV) Phase IIa
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hallux Abducto Valgus
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
timeFrame: Baseline and Week 8 in the double-blind treatment period
Secondary outcomes:
measure: LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12
timeFrame: Baseline and Weeks 4 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: Median Time to Retreatment
timeFrame: Up to 24 weeks in the double-blind treatment period
measure: LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12 in the double-blind treatment period
measure: LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12 in the double-blind treatment period
measure: Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12
timeFrame: Baseline and Weeks 8 and 12 in the double-blind treatment period
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas, Inc
state: Arkansas
city: Castro Valley
country: United States
facility: Center for Clinical Research Inc.
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: Los Angeles
country: United States
facility: Southwestern Academic Limb Salvage Alliance
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Santa Monica
country: United States
facility: University Foot and Ankle Institute
state: California
city: Thornton
country: United States
facility: Center for Spine and Orthopedics
state: Colorado
city: Miami
country: United States
facility: LCC Medical Research Institute
state: Florida
city: Orlando
country: United States
facility: Conquest Research
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Research
state: Florida
city: Belleville
country: United States
facility: Podiatry 1st
state: Illinois
city: Des Plaines
country: United States
facility: Weil Foot & Ankle Institute
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin Clinic
state: Illinois
city: Springfield
country: United States
facility: Foot and Ankle Center of Illinois
state: Illinois
city: Pasadena
country: United States
facility: The Chesapeake Research Group
state: Maryland
city: Saint Louis
country: United States
facility: Dr. Allen M. Jacobs and Associates
state: Missouri
city: Youngstown
country: United States
facility: Ankle and Foot Care Centers
state: Ohio
city: Oklahoma City
country: United States
facility: Medical Research International
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Foot and Ankle Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Foot and Ankle Center, INC
state: Pennsylvania
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Bio X Cell Research
state: Texas
city: Webster
country: United States
facility: Texas Gulf Coast Medical Group
state: Texas
city: Salt Lake City
country: United States
facility: Summit Foot & Ankle
state: Utah
city: Harrisonburg
country: United States
facility: Harrisonburg Foot and Ankle Clinic
state: Virginia
city: Suffolk
country: United States
facility: 1Foot 2Foot Centre for Foot and Ankle Care, PC
state: Virginia
city: Salem
country: United States
facility: Martinsville Research Institute, Inc.
state: West Virginia
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: