Status:
TERMINATED
Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Allergan
Conditions:
Neuropathic Pain
Allodynia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis. Neuropathic pain is pain ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01911377
Start Date
October 1 2013
End Date
August 1 2015
Last Update
October 2 2015
Active Locations (1)
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1
WRHA Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A IM4