Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS (NCT01911377) | Clinical Trial Compass
TerminatedPhase 2
Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS
Stopped: 12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.
Canada12 participantsStarted 2013-10
Plain-language 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 initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis.
Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.
Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain.
We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain.
24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brief Pain Inventory
Timeframe: Baseline and daily until study completion at 13 weeks