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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
NCT01911377 |
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Date of registration:
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25/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS
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Scientific title:
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The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01911377 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Karen Ethans, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Health Sciences Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Fulfills the criteria for neuropathic pain causing allodynia according to IASP pain
terminology.
- Allodynia that is resistant to, or has failed, the standard level of care measures
for more that six months.
- Allodynia pain on a daily basis.
- Allodynia pain that scores at least 4/10 on a pain numerical scale.
- Other pain medications(including antidepressants and anticonvulsants)have been
maintained at a stable dose for at least 2 months prior to enrollment.
- Ability to communicate in English.
Exclusion Criteria:
- Presence of other pain syndromes (e.g.,fibromyalgia, ongoing peripheral neuropathic
pain.
- Allergy to Botulinum Toxin Type A.
- Allergy to albumin.
- Use of Botulinum Toxin Type A for other treatment indications in the 3 months prior
to enrollment.
- Renal failure.
- Hepatic failure.
- Neuromuscular junction disorders.
- Bleeding diathesis.
- Cognitive impairment, dementia, major depression or psychotic disorder.
- Pregnant or breastfeeding.
- Infection at the injection site.
- Active alchohol or substance abuse.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neuropathic Pain
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Allodynia
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Intervention(s)
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Drug: Botulinum Toxin Type A
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Drug: Normal Saline for Injection
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Primary Outcome(s)
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Brief Pain Inventory
[Time Frame: Baseline and daily until study completion at 13 weeks]
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Secondary Outcome(s)
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Daily Sleep Interference Scale
[Time Frame: Baseline and daily during study period until week 13.]
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The Hospital Anxiety and Depression Scale
[Time Frame: Baseline and follow-up visits (at weeks 1, 4, 8 and 13).]
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Neuropathic Pain Symptom Inventory
[Time Frame: Baseline and follow-up visits(at weeks 1, 4, 8 and 13)]
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Clinician Global Impression Scale
[Time Frame: Final visit at week 13]
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Patient's Global Impression Scale
[Time Frame: Final visit at week 13]
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Secondary ID(s)
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Botox 2013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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