Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: A double-blind, randomized, placebo-controlled study (PINBOT)

Phase 1

Recruiting

Conditions: Diabetic neuropathic pain
MedDRA version: 21.1Level: LLTClassification code: 10067547Term: Diabetic peripheral neuropathic pain Class: 10029205
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: CTIS2022-500727-68-01

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

18 years of age or older, Diagnosed with diabetes mellitus, type I or II, Diagnosed with diabetic neuropathic pain that is a) by the participant as their dominant overall dominant pain b) rated at least 4 out of 10 of the NRS pain scale in both legs on average over the past 7 days c) fulfils the IASP criteria for Definite chronic neuropathic pain d) has been verified using nerveconduction studies e) present in both legs, below the knee f) has been present for at least 6 months, In a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study, Not been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion, Using an approved, safe contraceptive (for premenopausal women), Speak, read, and understand Danish

Exclusion Criteria

A known allergy or hypersensitivity to botulinumtoxin, Using or receiving treatment with cannabis products of any kind, Pregnant or planning pregnancy during the study period, A score of more than 25 on the Charlson Comorbidity Index, Treated with botulinumtoxin in the last 6 months, Diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis, A known malignant condition, An ongoing infection in the area of injection (right above the knee joint), Expect to change their pain medication during the study period, Diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as spinal stenosis, claudicatio, previous traume or nerve injury or cancer related pain., A psychiatric condition that affects their completion of the study, as assessed by the investigator., Active abusers of alcohol or illegal substances