Notalgia ParestheticaPhase 3NCT01098019
Treatment of Notalgia Paresthetica With Xeomin
A Phase 3 study testing Xeomin in people with Notalgia Paresthetica, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Notalgia Paresthetica
- What is being tested?
- Xeomin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Feb 2012
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 18 and 75 years of age at the time of consent
- Presence of notalgia paresthetica, resistant to topical therapy, for at least one year and stable for the past 3 months prior to Day 0.
- 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:
- Condom with spermicidal foam or jelly, sponge with spermicidal foam or jelly, diaphragm with spermicidal foam or jelly
- Intra uterine device (IUD)
- Contraceptives (oral or parenteral)
Show all 12Show fewer
- Nuvaring
- Vasectomy or vasectomised partner
- Surgically sterile or post-menopausal partner
- Same-sex partner
- Capable of giving informed consent; the consent must be obtained prior to any study related procedures.
- Negative urine pregnancy test (female of childbearing potential only)
Who cannot join
- Current Pregnancy of lactation
- Very mild notalgia paresthetica as defined by the absence of a clear zone of hyperpigmentation on the affected area on the back Severe notalgia paresthetica as defined by presence of excoriations, erosions or significant scarring in affected area on the back
- Use of any topical treatment on the affected area within 14 days of Day 0
- Use of botulinum toxin A within the past 12 weeks of Day 0
- Previous use of botulinum toxin A in the affected area on the back
- Use of systemic medication that can have an influence on pruritus such as antihistamines within 14 days of Day 0
Show all 10Show fewer
- Use of systemic corticosteroids within 28 days of Day 0
- Hypersensitivity to Xeomin
- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome)
- Presence of infection on the affected area on the back
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Notalgia Paresthetica
- Being tested
- Xeomin, Placebo / Xeomin
- Keywords
- Notalgia paresthetica, Xeomin, Botulinum Toxin A, Pruritus, Upper Back, Hyperpigmentation
- Medical subject headings
- Pruritus, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
Also called Botulinum Toxin A
Patients will receive Xeomin only at Day 0.
Placebo / XeominDrug
Also called Sodium Chloride, Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Xeomin | Experimental | 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). Receives: Drug: Xeomin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo / Xeomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 Weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Notalgia ParestheticaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Catherine Maari, MD, FRCPC, Principal investigator, Innovaderm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098019
- Sponsor's protocol ID
- Inno-6014
- Status last verified
- Apr 2012
- First submitted
- 1 Apr 2010
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Xeomin for the Treatment of Notalgia Paresthetica
- ClinicalTrials.gov ID
- NCT01098019
- Acronym / sponsor ID
- Inno-6014
- Conditions
- Notalgia Paresthetica
- Keywords
- Notalgia paresthetica, Xeomin, Botulinum Toxin A, Pruritus, Upper Back, Hyperpigmentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Apr 2010 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeomin | Experimental | Drug: XeominEach 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). |
| Placebo | Placebo comparator | Drug: Placebo / XeominPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or women between 18 and 75 years of age at the time of consent
- Presence of notalgia paresthetica, resistant to topical therapy, for at least one year and stable for the past 3 months prior to Day 0.
- 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:
- Capable of giving informed consent; the consent must be obtained prior to any study related procedures.
- Negative urine pregnancy test (female of childbearing potential only)
Key exclusion criteria (10 listed)
- Current Pregnancy of lactation
- Very mild notalgia paresthetica as defined by the absence of a clear zone of hyperpigmentation on the affected area on the back Severe notalgia paresthetica as defined by presence of excoriations, erosions or significant scarring in affected area on the back
- Use of any topical treatment on the affected area within 14 days of Day 0
- Use of botulinum toxin A within the past 12 weeks of Day 0
- Previous use of botulinum toxin A in the affected area on the back
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 |
|---|---|---|
| XeominAlso: Botulinum Toxin APatients will receive Xeomin only at Day 0. | Drug | Xeomin |
| Placebo / XeominAlso: Sodium Chloride, SalinePatients will receive 0.9% mL NaCl alone at Day 0. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin. | Drug | Placebo |
Primary outcome
Mean % difference in pruritus visual analog score (VAS).
Time frame: 8 Weeks
Changes from baseline in pruritus visual analogue score at Week 8 for patients randomized to Xeomin as compared to placebo
6 secondary outcomes
Mean % difference in area of hyperpigmentation
Time frame: 12 weeks
Mean % difference in area of hyperpigmentation
Time frame: 24 weeks
Mean number of days before re-appearance of pruritus
Time frame: 24 weeks
Mean global efficacy evaluated by investigator
Time frame: 12 weeks
Mean global efficacy evaluated by patient
Time frame: 12 weeks
Mean % difference in pruritus visual analogue score (VAS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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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.
Catherine Maari, MD, FRCPC principal investigator
Innovaderm Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xeomin in people with Notalgia Paresthetica, run by Innovaderm Research Inc. at 1 site in Canada.
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 12 inclusion and 10 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: finished, as of the sponsor's last update on 23 Apr 2012. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean % difference in pruritus visual analog score (VAS). (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2012.