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Dysport in Hallux Abducto Valgus (HAV) Phase IIa

NCT03569098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2021-07-02

Study results available
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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.

Conditions

  • Hallux Abducto Valgus

Interventions

BIOLOGICAL

Botulinum toxin type A

Investigators will inject the reconstituted solution into foot muscles.

DRUG

Placebo

Investigators will inject the reconstituted solution into foot muscles.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-12-17
Completion
2020-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569098 on ClinicalTrials.gov