Dysport in Vulvodynia Phase II Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    180
  • sponsor
    Ipsen
Updated on 2 December 2020
Investigator
Ipsen Recruitment Enquiries
Primary Contact
James A. Simon, MD, PC (6.4 mi away) Contact
+23 other location
botulinum toxin type a
dysport

Summary

This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia.

The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1; Dysport or placebo) followed by an open label treatment period. One or two optimally safe and effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2.

Details
Treatment Placebo, Botulinum Toxin Type A, Botulinum Toxin Type A (Dysport)
Clinical Study IdentifierNCT03598777
SponsorIpsen
Last Modified on2 December 2020

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