Botox as a treatment for chronic nerve pai

Phase 1

• Conditions: europathy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-507259-31-00
• Lead Sponsor: Aarhus Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-03
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age = 18 years, In one or more painful and neuro-anatomically relevant area is at least one of the following criteria present when compared to the contralateral side: (1) Hypoesthesia/anesthesia for touch (brush); Hypoesthesia/anesthesia for moderate cold (alcohol swab); (3) Hypoesthesia/anesthesia for moderate heat (thermo roller); (4) Hypoesthesia/anesthesia for pinprick (Neuropen); (5) Allodynia for touch (brush); (6) Allodynia for moderate cold (alcohol swab); (7) Allpdynia for moderate heat (Thermo roller); (8) Hyperalgesia for pinprick (Neuropen), Diagnostic ultrasound guided nerve block performed at the Nerve Injury Clinic at Aarhus University Hospital within the last 28 days before inclusion, where injection of local anesthetic around the neuropathic nerve(s) resulted in a pain reduction to NRS score 3 or below at the same provocation which previously resulted in maximal pain, American Society of Anesthesiologists physical status classification score (ASA) I-III, Suitable candidate for injection of botox (sponsor-investigator's assessment), Informed consent, Able to subjective evaluation of pain, Able to read and understand Danish and to read, understand and sign the informed consent form, Worst pain in rest/activity/at provocation NRS (Numeric rating scale) score = 5 in the primary area(s) of pain for at least 6 months at the time of inclusion, Has tried relevant medical first line treatment for the neuropathic pain where the treatment is currently stable or terminated, The localization of the painful skin area is neuro-anatomically plausible in relation to the suspected nerve damage (sponsor-investigator's assessment)

Exclusion Criteria

Know allergy towards Botulinum A or any substances listed in Produktresumé for ”BOTOX, pulver til injektionsvæske, opløsning 50, 100 og 200 Allergan-enheder”, Breast feeding or pregnancy. All women without verified menopause will be tested for pregnancy (urine HCG) on the day of inclusion. Verified menopause is defined as > 1 year since the last period without any other explanation and age >45 years, Abuse of alcohol or drugs (illegal and prescription drugs) assessed by sponsor-investigator, Participation in other clinical studies which may interfere with the present (sponsor-investigator's assessment), Any ongoing patient case/complaint related to the present cutaneous neuropathic pain, Not able to cooperate, Infection in the area around the site of injection, Significant competing pain which could interfere with the estimation of the treatment effect (sponsor-investigator's assessment), Current diagnosis of progressive neurological disease, Uncontrolled, severe systemic disease, Previous interventional pain treatment (e.g., spinal cord stimulation, cryoneurolysis, botox) without relevant effect for the same persisting, cutaneous neuropathic pain (note that Transcutaneous Electrical Nerve Stimulation, TENS, is not considered interventional), Previous injection of botox for the same persisting, cutaneous neuropathic pain, Number of nerves where the diagnostic nerve block provides pain relief is greater than 3

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to investigate the pain-relieving effect of perineural botox injection in patients with chronic cutaneous neuropathic pain;Secondary Objective: Secondary objectives include time to onset of the pain relieving effect, pain scores in rest, activity and at provocation, patient satisfaction, effect of the treatment on sleep and activity level and side effects.;Primary end point(s): The number of responders in the botox group versus the placebo group. Responders are defined as patients who at the 4 weeks follow-up, describe the pain-relieving effect in the neuropathic area(s) during the last 48 hours as mild, moderate or good.