NCT03663101

Dysport in Post-Surgical Neuralgia

A Double-blind, Randomised, Placebo Controlled, Proof-of-concept Study in Subjects With Abdominal or Thoracic Chronic Scar Pain to Assess the Analgesic Properties of Intradermal Doses of Dysport®

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to determine whether a currently licensed version of botulinum toxin (Dysport®) is effective for the treatment of pain that has developed and/or persisted for months or years around the scar of a previous surgical site, and whether this condition could be suitable for the testing of similar new medicines. The study will compare three different doses of Dysport® to see if there is benefit and/or a best dose for treating persistent post-surgery scar pain.

Conditions

• Chronic Scar Pain

Interventions

Type	Name	Description
DRUG	Lidocaine	0.5 mL (2.5 mg) of lidocaine per injection point will be injected subcutaneously (maximum 10 injection points).
BIOLOGICAL	Botulinum toxin type A	0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).
DRUG	Placebo	Part A - 0.5 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected subcutaneously (maximum 10 injection points).
DRUG	Placebo	Part B - 0.2 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected intradermally (maximum 10 injection points, 2,0 mL maximum).

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2018-09-10
• Last updated: 2021-01-12
• Results posted: 2020-12-04

Locations

1 site across 1 country: United Kingdom