Abstract Details

Title Paving the Way for a New Local Peripheral Neuropathic Pain Treatment: Proof-of-Concept Clinical Trial With IncobotulinumtoxinA (PaiNT)

Topic Pain

Presentation(s) P8 - Poster Session 8 (11:45 AM-12:45 PM)

Poster/Presentation
Number 14-007

Objective

First evidence with local Botulinum neurotoxin type A (BoNT/A) treatment in Peripheral Neuropathic Pain (PNP) has shown a superior number-needed-to-treat, compared to other pharmacological treatments.

Background

Overall, 6-10% of adults are suffering from chronic pain with neuropathic features. Affected patients are significantly impacted in their physical, social, economic, and psychological well-being. Existing therapies are limited by insufficient treatment effect and side effects, resulting in a huge unmet medical need.

Design/Methods

Most previous clinical trials with BoNT/A were small, single centre, and with potential bias. This resulted in a weak GRADE recommendation for use as third line treatment in PNP patients. To fill the existing evidence gap, the ongoing phase 2 proof-of-concept clinical trial (PaiNT) investigates efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin^®), a BoNT/A free from complexing proteins.

Results This randomised, double-blind, multicentre (31 sites, 6 countries), clinical trial is designed to include ≥120 adults with moderate to severe chronic PNP due to postherpetic neuralgia or peripheral nerve injury after surgery or mechanical trauma. Bedside Quantitative Sensory Testing (QST), aimed at patients’ phenotyping, is used for the first time in a BoNT/A clinical trial. Patients receive subcutaneous injections into the painful area with either incobotulinumtoxinA (≤300 units) or placebo and are followed-up for 20 weeks. The trial evaluations include changes in Average Daily Pain intensity, Neuropathic Pain Symptom Inventory, and safety endpoints

Conclusions

The large-scale PaiNT trial, investigating incobotulinumtoxinA in patients with PNP, may pave the way for a new local treatment of this burdensome condition.

Authors/Disclosures
Nadine Attal, MD, PhD (APHP and INSERM U 987, Hospital Ambroise Pare) PRESENTER	Dr. Attal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grunenthal. Dr. Attal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz . Dr. Attal has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz . Dr. Attal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Maxona . Dr. Attal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Grunenthal . Dr. Attal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic . Dr. Attal has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier . Dr. Attal has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wolter Kluwers.
Irena Pulte	Irena Pulte has received personal compensation for serving as an employee of Merz Pharmaceuticals . Irena Pulte has received intellectual property interests from a discovery or technology relating to health care.
Ilona Bicker, MD	Dr. Bicker has received personal compensation for serving as an employee of Merz Therapeutics GmbH. Dr. Bicker has received intellectual property interests from a discovery or technology relating to health care.
Nanna Brix Finnerup	Prof. Finnerup has received personal compensation in the range of $0-$499 for serving as a Consultant for NeuroPN, Saniona, PharmNovo, Tris Pharma. Prof. Finnerup has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for IASP.
Thorin Geister, PhD	Dr. Geister has received personal compensation for serving as an employee of Merz Therapeutics GmbH.
Eric J. VIEL, MD, PhD	Prof. VIEL has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grünenthal company. Prof. VIEL has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz pharmaceutical. The institution of Prof. VIEL has received research support from Merz therapeutics.

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