Dysport in Hallux Abducto Valgus (HAV) Phase IIa
DYSTANCE
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
1 other identifier
interventional
186
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2018
CompletedStudy Start
First participant enrolled
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2020
CompletedResults Posted
Study results publicly available
July 2, 2021
CompletedJuly 2, 2021
July 1, 2021
1.5 years
June 14, 2018
May 7, 2021
July 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
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).
Baseline and Week 8 in the double-blind treatment period
Secondary Outcomes (13)
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 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 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
- +8 more secondary outcomes
Study Arms (3)
Dysport Dose 1
EXPERIMENTALIntramuscular 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.
Dysport Dose 2
EXPERIMENTALIntramuscular 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.
Placebo
PLACEBO COMPARATORIntramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
Interventions
Investigators will inject the reconstituted solution into foot muscles.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of HAV
- Painful HAV in the study foot at Baseline
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (29)
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, 72212, United States
Center for Clinical Research Inc.
Castro Valley, California, 94546, United States
Limb Preservation Platform, Inc.
Fresno, California, 93710, United States
Southwestern Academic Limb Salvage Alliance
Los Angeles, California, 90033, United States
Foot and Ankle Clinic
Los Angeles, California, 90057, United States
University Foot and Ankle Institute
Santa Monica, California, 90403, United States
Center for Spine and Orthopedics
Thornton, Colorado, 80229, United States
LCC Medical Research Institute
Miami, Florida, 33126, United States
Conquest Research
Orlando, Florida, 32822, United States
Doctors Research Network
South Miami, Florida, 33301, United States
Clinical Research
West Palm Beach, Florida, 33406, United States
Podiatry 1st
Belleville, Illinois, 62226, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016, United States
Rosalind Franklin Clinic
North Chicago, Illinois, 60064, United States
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704, United States
The Chesapeake Research Group
Pasadena, Maryland, 21122, United States
Dr. Allen M. Jacobs and Associates
St Louis, Missouri, 63117, United States
Ankle and Foot Care Centers
Youngstown, Ohio, 22801, United States
Medical Research International
Oklahoma City, Oklahoma, 73109, United States
Foot and Ankle Center
Bryn Mawr, Pennsylvania, 19010, United States
Harrisburg Foot and Ankle Center, INC
Harrisburg, Pennsylvania, 17112, United States
Futuro Clinical Trials, LLC
McAllen, Texas, 78501, United States
Bio X Cell Research
San Antonio, Texas, 78229, United States
Texas Gulf Coast Medical Group
Webster, Texas, 77598, United States
Summit Foot & Ankle
Salt Lake City, Utah, 84117, United States
Harrisonburg Foot and Ankle Clinic
Harrisonburg, Virginia, 22801, United States
1Foot 2Foot Centre for Foot and Ankle Care, PC
Suffolk, Virginia, 23434, United States
Martinsville Research Institute, Inc.
Salem, West Virginia, 24153, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Based on the results of the primary analysis the sponsor terminated the study early due to lack of efficacy of the tested doses at the primary endpoint. The decision by the sponsor to terminate the study early was not related to any safety or tolerability concerns with Dysport.
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen Pharma
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2018
First Posted
June 26, 2018
Study Start
June 19, 2018
Primary Completion
December 17, 2019
Study Completion
May 22, 2020
Last Updated
July 2, 2021
Results First Posted
July 2, 2021
Record last verified: 2021-07