Notalgia Paresthetica Clinical Trial
Official title:
Efficacy and Safety of Xeomin for the Treatment of Notalgia Paresthetica
Patients will be randomized (1:1) to receive either injections of Xeomin in 0.9% NaCl or NaCl alone. Xeomin will be reconstituted with 2 mL of NaCl 0.9 which will give a final concentration of 5 U of botulinum toxin A per 0.1 mL. The area affected will be injected with 0.1 mL at each 1-2 cm2 for a maximum total dose of 200 units. Patients will be evaluated at Weeks 8, 12, 18 and 24. An unblinded pharmacist or designee will prepare placebo and Xeomin injections. Patients will be unblinded at the end of the week 12 visit. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin while patients initially randomized to Xeomin will not be injected. All patients will be seen for follow-up visits at Weeks 18 and 24. Efficacy in reducing pruritus will be measured with a 10 cm visual analogue score. This will be performed at Day 0, Week 8, Week 12, Week 18 and Week 24. Efficacy will also be measured by measuring the area of the hyperpigmented zone on the back. Safety will be evaluated with adverse events.
Notalgia paresthetica is a common sensory neuropathy, affecting mainly the interscapular
area especially the T2-T6 dermatomes. The characteristic symptom is pruritus on the upper
back. It is occasionally accompanied by pain, paresthesia, hyperesthesia and a well
circumscribed hyperpigmentation of the affected area. The correlation of notalgia
paresthetica localization with corresponding degenerative changes in the spine suggest that
spinal nerve impingement may be a contributing cause. Topical treatments such as
corticosteroids, menthol, capsaicine and pramoxine are usually not very effective. Patients
are very affected in their daily activities by this chronic condition and usually
disappointed by the current available treatments.
A recent publication reports success in treating 2 patients with notalgia paresthetica with
botulinum toxin A. In both cases a complete response for pruritus was noted. The major
limitations of this publication are the small number of cases (two) and the fact that there
was no control. The mechanism of action of botulinum toxin A in nostalgia paresthetica has
not been investigated.
However the beneficial effects of botulinum toxin A on other diseases causing pruritus and
pain has previously been reported. Botulinum toxin A has been shown to prevent the release
of substance P, a well known mediator involved in pain and itch, and this may explain its
efficacy in pruritic diseases. This proposal plans to study the efficacy and safety of
botulinum toxin A (Xeomin) for the treatment of notalgia paresthetica in a randomized
placebo controlled trial. Botulinum toxin A prevents the release of neuromediators such as
acetylcholine. Botulinum toxin A has been used for many years to treat various disorders
including blepharospasm, spasmodic torticollis, post stroke spasticity of the upper limbs,
strabismus, palmar and axillary hyperhidrosis and wrinkles. This study will use Xeomin, a
purified botulinum clostridium neurotoxin A that has recently been approved by Health
Canada. Xeomin is currently approved for the treatment of blepharospasm, spasmodic
torticollis and post stroke spasticity of the upper limbs.
A recent publication reported success in treating two patients with notalgia paresthetica
with botulinum toxin A. In both cases a complete response of pruritus was noted. One patient
was still symptom free after 18 months while the other patient had a mild resurgence of
pruritus at 18 months. The major limitations of this publication are the small number of
cases (two) and the fact that there was no control. The current proposal plans to study the
efficacy and safety of botulinum toxin A for the treatment of notalgia paresthetica in a
randomized placebo controlled trial. In this study Xeomin will be reconstituted and used
according to the approved Canadian Product Monograph.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04706975 -
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
|
Phase 2 | |
| Terminated |
NCT05978063 -
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
|
Phase 2/Phase 3 |