Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities

NCT05623111 | Recruiting Phase 2

• 1 other identifier: PINBOT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs. The main questions it aims to answer are:

• Is the treatment safe and effective?
• Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation? Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

• Changes in daily neuropathic pain scores

  Differences in pain scores, as measured by the Numeric Rating Scale (0-11), between groups.

  Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Outcome is defined as differences in change from baseline of average daily and weekly pain scores between groups.

Secondary Outcomes (9)

• Use of rescue medication

  Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Defined as differences in change from baseline of average days per week of rescue medication usage across the study period.

• Neuropathic Pain Symptom Inventory

  Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.

• Health-related quality of life

  Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.

• Activities of daily living

  Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.

• Physical activity

  Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.

Study Arms (2)

Incobotulinumtoxin-A

ACTIVE COMPARATOR

100 units of incobotulinumtoxin-A in 5ml of sterile saline around both distal ischial nerves.

Drug: Incobotulinumtoxin-A 100 UNIT Injection

Placebo

PLACEBO COMPARATOR

5ml sterile saline with small amounts of human albumin and sucrose (identical to binding agents in active vials)

Drug: Saline

Interventions

Incobotulinumtoxin-A 100 UNIT Injection DRUG

Perineural injection

Incobotulinumtoxin-A

Saline DRUG

Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.

Placebo

Eligibility Criteria

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

You may qualify if:

• Are 18 years or older
• Are diagnosed with diabetes type I or II
• Score 3 or above on the Doleur Neuropathique 4 interview section
• Suffer from pain of the lower extremities which
• is considered by the participant as their dominant overall dominant pain
• is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days)
• is present in both feet, roughly symmetrically.
• has been present for at least 6 months
• Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40.
• Are using an approved, safe contraceptive (for premenopausal women)
• Speak, read, and understand Danish

You may not qualify if:

• Have a known allergy or hypersensitivity to BonT-A
• Have been treated with BonT in the last 6 months.
• Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Have a known malignant condition
• Have an ongoing infection in the area of injection
• Are expecting to change their pain medication during the study period
• Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as:
• spinal stenosis
• claudication
• previous trauma or nerve injury
• cancer related pain
• Have a psychiatric condition that affects their completion of the study, as assessed by the investigator.
• Are active abusers of alcohol or illegal substances
• Are using or receiving treatment with cannabis products of any kind
• Are pregnant or planning pregnancy during the study period

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Merz Pharmaceuticals GmbH: collaborator
• Toyota Foundation Denmark: collaborator
• Steno Diabetes Center Zealand Region: collaborator
• Shipwright Per Henriksen, R., and wife Foundation: collaborator
• The GCP unit at Copenhagen University Hospital: collaborator
• Capital Region Pharmacy, Denmark: collaborator

Study Sites (1)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Related Publications (1)

• Klee M, Hormann Thomsen T, Enggaard TP, Bitsch MS, Simonsen L, Jensen RH, Biering-Sorensen B. Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study). BMJ Open. 2024 Jan 22;14(1):e074372. doi: 10.1136/bmjopen-2023-074372.

  PMID: 38262642 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bo Biering-Sørensen, MD

  Neurological Pain Clinic, Rigshospitalet

  STUDY DIRECTOR

Central Study Contacts

Marc Klee Olsen, MD

CONTACT

+4538633030; marc.klee.olsen@regionh.dk

Trine Thomsen, MsC

CONTACT

+4538632712; trine.hoermann.thomsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Model Details: 2-armed active/placebo 1:1 ratio

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 21, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be published as supplementary material to publications.
• Access Criteria: Open Access

Locations

DK (1)