Dysport in Post-Surgical Neuralgia (RESPITE)
Research type
Research Study
Full 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®\n
IRAS ID
248526
Contact name
Richard Langford
Contact email
Sponsor organisation
Ipsen Innovation SAS
Eudract number
2018-001703-37
Duration of Study in the UK
0 years, 6 months, 20 days
Research summary
This 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. \nThis study will compare three different doses of Dysport® to see if there is benefit and/or a best dose for treating persistent post-surgery pain around the surgical scar. \nThe study is being conducted at the central London research unit of St Pancras Clinical Research. Approximately 60 participants will be consented to take part in the study, consisting of two parts: two test injection sessions (a week apart) in the first phase will decide whether the subject goes on to receive the actual study medicine injections in the second phase of the study. (It is anticipated that around half of the Phase 1 subjects will proceed to Phase 2).\nParticipation in both phases will last approximately five months, and subjects will be required to attend the Clinical Research Unit on eight occasions. \n
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1216
Date of REC Opinion
6 Sep 2018
REC opinion
Further Information Favourable Opinion