NeuralgiaNCT06036043
Botulinum Toxin for Chronic Neuropathic Pain
An observational study of Neuralgia and Chronic Pain, run by Region Zealand at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Chronic Pain
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic neuropathic pain
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University Hospital of regions Zealand
Køge, 4600
Rune Frederiksen, 26802789, Rune@acamedia.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuralgia, Chronic Pain
- Being tested
- Botulinum toxin type A
- Keywords
- Botulinum Toxin, chronic pain, neuropathic pain
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Xeomin
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.
- 100 IU Xeomin is mixed with 4 ml NaCl. Injections are performed with a 1.5 cm spacing. Maximum of 40 injections (200 IU).
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Patients treated with Botulinum Toxin Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Up to 7 months after initiating treatment
Frequency of serious adverse reactions
Frequency of serious adverse reactions (according to ICH-GCP definition).
Measured: Up to 7 months after initiating treatment
Secondary outcomes (3)
EuroQol-5 Dimension (EQ-5D)
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')
Measured: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Neuropathic Pain Symptom Inventory (NPSI)
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')
Measured: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Onset and duration
Time from treatment before onset of effect and duration of effect
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rune Frederiksen, Region Zealand
- Investigators
- Thomas Peter Enggaard, MD, PHD, Study director, Copenhagen University Hospital, RigshospitaletOle Mathiesen, MD, PHD, Study director, University Hospital of Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036043
- Sponsor's protocol ID
- RegionSealand
- Status last verified
- Sep 2023
- First submitted
- 14 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28388718Egeo 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.
PubMed 32849195Datta 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.
PubMed 35051013Meyer-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.
PubMed 31148462Finnerup 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.
PubMed 25575710Lippi 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.
PubMed 35622555Attal 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.
PubMed 26947719
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin for Chronic Neuropathic Pain - an Interventional Open Label Study at the Interdisciplinary Pain Center, Zealand University Hospital
- ClinicalTrials.gov ID
- NCT06036043
- Acronym / sponsor ID
- RegionSealand
- Conditions
- Neuralgia, Chronic Pain
- Keywords
- Botulinum Toxin, chronic pain, neuropathic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Drug: Botulinum toxin type APatients treated with Botulinum Toxin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic neuropathic pain
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: XeominThe 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. | Drug | Intervention group |
Primary outcome
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.
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.
Frequency of serious adverse events
Time frame: Up to 7 months after initiating treatment
Frequency of serious adverse events (according to ICH-GCP definition).
Frequency of serious adverse reactions
Time frame: Up to 7 months after initiating treatment
Frequency of serious adverse reactions (according to ICH-GCP definition).
3 secondary outcomes
EuroQol-5 Dimension (EQ-5D)
Time frame: 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®).
Onset and duration
Time frame: At 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 28388718Monheit GD, Pickett A. AbobotulinumtoxinA: A 25-Year History. Aesthet Surg J. 2017 May 1;37(suppl_1):S4-S11. doi: 10.1093/asj/sjw284.
- Background: PubMed 32849195Egeo 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.
- Background: PubMed 35051013Datta 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.
- Background: PubMed 31148462Meyer-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.
- Background: PubMed 25575710Finnerup 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.
- Background: PubMed 35622555Lippi 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.
- Background: PubMed 26947719Attal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Peter Enggaard, MD, PHD study director
Copenhagen University Hospital, Rigshospitalet
Ole Mathiesen, MD, PHD study director
University Hospital of Region Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuralgia and Chronic Pain, run by Region Zealand at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rune Frederiksen, MD (26802789, Rune@acamedia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal pain intensity (time frame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036043, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.