Skip to content

Dysport in Post-Surgical Neuralgia

CompletedPhase 2NCT03663101
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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®
Conditions
  • Chronic Scar Pain
Sponsor
Ipsen
Start date
2018-10-30
Primary completion
2019-11-08
Sex
All
Age range
from 18 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United Kingdom
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male and female subjects aged between 18 and 75 years inclusive at the time of giving informed consent. * Subjects suffering from an area of chronic pain post-abdominal or thoracic surgery, chronic abdominal or thoracic scar pain. * Longitudinal axis of the pain area of 10 cm long maximum (as mapped upon screening). * Subjects with moderate to severe pain, i.e. spontaneous NRS score of 4-8 which has been stable for the previous month before screening. * Stable use of analgesics (or any medication impacting pain perception) during the month before screening and expected to be stable for the study duration. * Under stable medication regimen for other medication, i.e. during the month before screening. * Time from surgery which caused the painful scar more than six months and less than ten years at screening. * No other distracting pain either chronic or acute. * Female subjects of childbearing potential must have a negative urine pregnancy test result and be willing to use reliable contraceptive measures throughout study participation. * The subject's primary care physician has provided evidence which can be used to confirm that within the last 12 months of dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study. Exclusion Criteria: * Previous treatment with Botulinum neurotoxin (BTX) (any serotype) during the past six months before screening. * History of hypersensitivity to any of the components of the Dysport formulation (which includes human serum albumin and lactose) or allergy to cow's milk protein. * Known hypersensitivity to lidocaine or other anaesthetics of the amide type, known hypersensitivity to hydroxybenzoates, complete heart block, hypovolaemia. * Any medical condition that may put the subject at risk with exposure to BTX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function. * Opioid analgesic use at a Morphine Equivalent Dosage (MED) of \>75mg per day. * Neuroma in the scar pain area, diagnosed per ultrasound. * Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine. * Need of any prohibited medication. * Any abnormal laboratory value, physical examination, vital signs, or electro…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03663101