A Phase 3 interventional study of Xeomin and Placebo / Xeomin in Notalgia Paresthetica, sponsored by Innovaderm Research Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-04-23.
Sponsored by Innovaderm Research Inc. · Phase 3, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Unless surgically sterile (or at least 1 year post-menopausal for women), or abstinent, patient (male or female) is willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 12 months after the last drug administration. Effective method of contraception include:
Exclusion Criteria:
Each bottle of 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 square cm for a maximum total dose of 200 units (4mL).
Drug: Xeomin
Patients will receive 0.9% mL NaCl alone. The area affected will be injected with 0.1 mL at each 1-2 square cm for a maximum volume of 4 mL.
Drug: Placebo / Xeomin
Patients will receive Xeomin only at Day 0.
Also known as: Botulinum Toxin A
Patients will receive 0.9% mL NaCl alone at Day 0. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin.
Also known as: Sodium Chloride, Saline
Mean % difference in pruritus visual analog score (VAS).
Changes from baseline in pruritus visual analogue score at Week 8 for patients randomized to Xeomin as compared to placebo
Time frame: 8 Weeks
Mean % difference in area of hyperpigmentation
Changes from baseline in area of hyperpigmentation on the affected zone of the back at Week 12 for patients randomized to Xeomin as compared to placebo
Time frame: 12 weeks
Mean % difference in area of hyperpigmentation
Changes from baseline in area of hyperpigmentation on the affected zone of the back at Week 24 as compared to baseline for patients randomized to Xeomin
Time frame: 24 weeks
Mean number of days before re-appearance of pruritus
Duration of efficacy as measured by changes from baseline in pruritus visual analogue score overtime for patients randomized to Xeomin
Time frame: 24 weeks
Mean global efficacy evaluated by investigator
Global efficacy of treatment as evaluated by the investigator at Week 12 for patients randomized to Xeomin as compared to placebo
Time frame: 12 weeks
Mean global efficacy evaluated by patient
Global efficacy of treatment as evaluated by patients at Week 12 for patients randomized to Xeomin as compared to placebo
Time frame: 12 weeks
Mean % difference in pruritus visual analogue score (VAS)
Changes from baseline in pruritus visual analogue score at Week 12 for patients randomized to Xeomin as compared to placebo
Time frame: 12 weeks
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Innovaderm Research Inc.