Botulinum Toxin for Chronic Neuropathic Pain

September 11, 2023 updated by: Rune Frederiksen, Region Zealand

Botulinum Toxin for Chronic Neuropathic Pain - an Interventional Open Label Study at the Interdisciplinary Pain Center, Zealand University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

There are eight randomized controlled trials investigating the effectiveness of BoNT for peripheral neuropathic pain. The indications in the studies include diabetic neuropathy, post-herpetic neuropathy, and peripheral nerve injury. Overall, the studies indicate a treatment effect that is significantly better than placebo. However, the studies are relatively small, their outcome measures vary, making comparison difficult, and there is considerable variation in the degree of pain reduction. The duration of the effect of BoNT treatment varies greatly and has not been systematically studied. The current evidence provides a promising background in the treatment of BoNT og neuropathic pain, but further research and documentation are needed.

At the Interdisciplinary Pain Center, Zealand University Hospital, BoNT treatment is already used for patients with neuropathic pain, who do not respond to 1. and 2. line treatments. This study will evaluate the efficacy of the treatment.

Method:

The objective of this study is to prospectively follow a one-year cohort and subsequently conduct a follow-up of 7 months (three treatments) for patients initiating BoNT treatment. The follow-up includes monitoring the treatment's effectiveness, duration, and recording adverse reactions.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Recruiting
        • University Hospital of regions Zealand
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic neuropathic pain

Description

Inclusion Criteria:

  • Condition of neuropathic pain verified by paraclinical examination or supported by underlying diseases (e.g., diabetes or herpes zoster).
  • The condition is characterized by allodynia, hyperalgesia, and/or neuralgiform symptoms such as burning and stabbing pain.
  • The affected area can be identified through objective examination with detection of disturbances in touch using cotton swabs, pin-prick, and/or vibration

Exclusion Criteria:

  • Mixed etiology of pain not solely attributable to neuropathy (e.g., fibromyalgia and neuropathy or nociceptive pain and neuropathy).
  • Contraindication to BoNT treatment (allergy to the toxin).
  • Pregnancy.
  • Diseases where BoNT treatment is contraindicated, such as motor neuron diseases and muscular dystrophy.
  • Severe psychiatric disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group
Patients treated with Botulinum Toxin
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.

Other Names:
  • Xeomin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal pain intensity
Time Frame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Proportion of patients with clinically relevant reduction in maximum pain (last 24 hours) compared to baseline, assessed using the Numerical Rating Scale (NRS 0-10; Zero represents 'no pain at all' and the upper limit represents 'the worst pain ever possible'). A minimal important difference (MID) of NRS 1 is considered as clinically relevant.
At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
pain intensity at rest
Time Frame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®)
Proportion of patients with clinically relevant reduction in average pain at rest (last 24 hours) compared to baseline, assessed using the Numerical Rating Scale (NRS 0-10). A MID of NRS 1 is considered as clinically relevant.
At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®)
Frequency of serious adverse events
Time Frame: Up to 7 months after initiating treatment
Frequency of serious adverse events (according to ICH-GCP definition).
Up to 7 months after initiating treatment
Frequency of serious adverse reactions
Time Frame: Up to 7 months after initiating treatment
Frequency of serious adverse reactions (according to ICH-GCP definition).
Up to 7 months after initiating treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol-5 Dimension (EQ-5D)
Time Frame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Change in health-related quality of life (EQ-5D) compared to baseline. EQ-5D includes pain evaluation using the visual analogue scale (VAS 0-100; Zero represents 'no pain at all' and the upper limit represents 'the worst pain ever possible')
At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Change in neuropathic pain compared to baseline using the NPSI that evaluates 12 different symptoms according to a numerical rating scale from 0 to 10 (Zero represents 'no pain at all' and the upper limit represents 'the worst pain ever possible')
At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Onset and duration
Time Frame: At 28 days
Time from treatment before onset of effect and duration of effect
At 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Zealand

Investigators

  • Study Director: Thomas Peter Enggaard, MD, PHD, Rigshospitalet, Denmark
  • Study Director: Ole Mathiesen, MD, PHD, University Hospital of Region Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegionSealand

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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