Dysport in Hallux Abducto Valgus (HAV) Phase IIa

Completed · Phase 2 · Has a placebo group

Conditions studied: Hallux Abducto Valgus

In brief

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.

Key facts

Study ID

NCT03569098

Run by

Ipsen

People needed

186

Starts

2018-06-19

Expected to finish

2020-05-22

Last updated by the study team

2021-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Applied Research Center of Arkansas, Inc — Little Rock, Arkansas, United States
• Center for Clinical Research Inc. — Castro Valley, California, United States
• Limb Preservation Platform, Inc. — Fresno, California, United States
• Southwestern Academic Limb Salvage Alliance — Los Angeles, California, United States
• Foot and Ankle Clinic — Los Angeles, California, United States
• University Foot and Ankle Institute — Santa Monica, California, United States
• Center for Spine and Orthopedics — Thornton, Colorado, United States
• LCC Medical Research Institute — Miami, Florida, United States
• Conquest Research — Orlando, Florida, United States
• Doctors Research Network — South Miami, Florida, United States
• Clinical Research — West Palm Beach, Florida, United States
• Podiatry 1st — Belleville, Illinois, United States
• Weil Foot & Ankle Institute — Des Plaines, Illinois, United States
• Rosalind Franklin Clinic — North Chicago, Illinois, United States
• Foot and Ankle Center of Illinois — Springfield, Illinois, United States
• The Chesapeake Research Group — Pasadena, Maryland, United States
• Dr. Allen M. Jacobs and Associates — St Louis, Missouri, United States
• Ankle and Foot Care Centers — Youngstown, Ohio, United States
• Medical Research International — Oklahoma City, Oklahoma, United States
• Foot and Ankle Center — Bryn Mawr, Pennsylvania, United States
• Harrisburg Foot and Ankle Center, INC — Harrisburg, Pennsylvania, United States
• Futuro Clinical Trials, LLC — McAllen, Texas, United States
• Bio X Cell Research — San Antonio, Texas, United States
• Texas Gulf Coast Medical Group — Webster, Texas, United States

Full record on ClinicalTrials.gov

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