drugset / Trial / NCT03569098
Dysport in Hallux Abducto Valgus (HAV) Phase IIa
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2018-06-19
- Primary completion
- 2019-12-17
- Completion
- 2020-05-22
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Dysport 300 U; p = 0.7669; Difference in LS mean 0.32 (95% CI -0.55 to 1.19) NCT03569098 ↗
registry analysis (superiority test); Placebo vs Dysport 500 U; p = 0.2085; Difference in LS mean -0.36 (95% CI -1.24 to 0.51) NCT03569098 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | — | Intramuscular |
Indications
No indication recorded.