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Botulinum Toxin for Chronic Neuropathic Pain

NCT06036043 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-09-13

No results posted yet for this study

Summary

Treatment of peripheral neuropathic pain with Botulinum Toxin (BoNT) has showed promising results since the first study was released in 2001. Further research, however, is needed in order to strengthen the treatment, and a number of questions are unanswered. This includes which indication is the treatment the most effective, how should the treatment be administered, what is the duration of the effect? This study is a prospective interventional open label study, designed to assess the efficacy and safety of Botolinum toxin in the treatment of chronic neuropathic pain.

Conditions

Interventions

DRUG

Botulinum toxin type A

The treatment will be administered either as a) subcutaneous infiltration with BoNT, covering the painful area, identified as allodynia during sensory examination, or b) perineural injection corresponding to the peripheral nerve(s) innervating the area where the pain is localized. 1. 100 IU Xeomin is mixed with 4 ml NaCl. Injections are performed with a 1.5 cm spacing. Maximum of 40 injections (200 IU). 2. 100 IU of botulinum toxin is mixed with 10 ml NaCl. For administration around multiple nerves, 50-100 IU per nerve (maximum 300 IU). The treatment will primarily be provided by the principal investigator, or an anesthesiologist specializing in nerve blocks. The specific method will be determined on an individual basis. If there is no effect after one to two treatments, the treatment will be considered ineffective and discontinued. A treatment interval of 3 months has been established in accordance with a previous larger study.

Sponsors & Collaborators

  • Region Zealand

    lead OTHER

Principal Investigators

  • Thomas Peter Enggaard, MD, PHD · Rigshospitalet, Denmark

  • Ole Mathiesen, MD, PHD · University Hospital of Region Zealand

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-11-01
Completion
2024-12-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06036043 on ClinicalTrials.gov