Botulinum Toxin for Chronic Neuropathic Pain

NCT06036043 | Unknown

• 1 other identifier: RegionSealand
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Neuralgia; Chronic Pain

Keywords

Botulinum Toxin; chronic pain; neuropathic pain

Outcome Measures

Primary Outcomes (4)

• Maximal pain intensity

  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

  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

  Frequency of serious adverse events (according to ICH-GCP definition).

  Up to 7 months after initiating treatment

• Frequency of serious adverse reactions

  Frequency of serious adverse reactions (according to ICH-GCP definition).

  Up to 7 months after initiating treatment

Secondary Outcomes (3)

• EuroQol-5 Dimension (EQ-5D)

  At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).

• Neuropathic Pain Symptom Inventory (NPSI)

  At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).

• Onset and duration

  At 28 days

Study Arms (1)

Intervention group

Patients treated with Botulinum Toxin

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

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.

Also known as: Xeomin

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic neuropathic pain

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Zealand: lead

Study Sites (1)

University Hospital of regions Zealand

Køge, 4600, Denmark

RECRUITING

Related Publications (7)

• Monheit GD, Pickett A. AbobotulinumtoxinA: A 25-Year History. Aesthet Surg J. 2017 May 1;37(suppl_1):S4-S11. doi: 10.1093/asj/sjw284.

  PMID: 28388718 BACKGROUND

• Egeo G, Fofi L, Barbanti P. Botulinum Neurotoxin for the Treatment of Neuropathic Pain. Front Neurol. 2020 Aug 11;11:716. doi: 10.3389/fneur.2020.00716. eCollection 2020.

  PMID: 32849195 BACKGROUND

• Datta Gupta A, Edwards S, Smith J, Snow J, Visvanathan R, Tucker G, Wilson D. A Systematic Review and Meta-Analysis of Efficacy of Botulinum Toxin A for Neuropathic Pain. Toxins (Basel). 2022 Jan 3;14(1):36. doi: 10.3390/toxins14010036.

  PMID: 35051013 BACKGROUND

• Meyer-Friessem CH, Eitner LB, Kaisler M, Maier C, Vollert J, Westermann A, Zahn PK, Avila Gonzalez CA. Perineural injection of botulinum toxin-A in painful peripheral nerve injury - a case series: pain relief, safety, sensory profile and sample size recommendation. Curr Med Res Opin. 2019 Oct;35(10):1793-1803. doi: 10.1080/03007995.2019.1626228. Epub 2019 Jul 9.

  PMID: 31148462 BACKGROUND

• Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.

  PMID: 25575710 BACKGROUND

• Lippi L, de Sire A, Folli A, D'Abrosca F, Grana E, Baricich A, Carda S, Invernizzi M. Multidimensional Effectiveness of Botulinum Toxin in Neuropathic Pain: A Systematic Review of Randomized Clinical Trials. Toxins (Basel). 2022 Apr 27;14(5):308. doi: 10.3390/toxins14050308.

  PMID: 35622555 BACKGROUND

• Attal N, de Andrade DC, Adam F, Ranoux D, Teixeira MJ, Galhardoni R, Raicher I, Uceyler N, Sommer C, Bouhassira D. Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2016 May;15(6):555-65. doi: 10.1016/S1474-4422(16)00017-X. Epub 2016 Mar 2.

  PMID: 26947719 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Thomas Peter Enggaard, MD, PHD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Ole Mathiesen, MD, PHD

  University Hospital of Region Zealand

  STUDY DIRECTOR

Central Study Contacts

Rune Frederiksen, MD

CONTACT

26802789; Rune@acamedia.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 13, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

DK (1)