Dysport in Hallux Abducto Valgus (HAV) Phase IIa (DYSTANCE)

Ipsen

Status and phase: Completed; Phase 2

Conditions: Hallux Abducto Valgus

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03569098

D-FR-52120-237

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

186 participants in 3 patient groups, including a placebo group

Dysport Dose 1

Experimental group

Description:

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.

Treatment:

Biological: Botulinum toxin type A

Dysport Dose 2

Experimental group

Description:

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.

Treatment:

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Description:

Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)

Treatment:

Drug: Placebo