Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS

University of Manitoba

Status and phase: Terminated; Phase 2

Conditions: Allodynia; Neuropathic Pain

Treatments: Drug: Normal Saline for Injection; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01911377

Botox 2013

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Arm 1: Botulinum Toxin Type A

Active Comparator group

Description:

200 units of Botulinum Toxin Type a will be administered intradermally to the allodynic area chosen for study.The allodynic area will be mapped, and the number of injections needed to cover the allodynic area without exceeding 40 injection sites will be determined. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any discomfort caused by the injections.

Treatment:

Drug: Botulinum Toxin Type A

Arm 2: Normal Saline for Injection

Placebo Comparator group

Description:

Normal saline for intradermal injection will be prepared by the Investigational Pharmacy in a manner as to be indistinguishable from active drug. The allodynic area will be mapped so as to determine the number of injections needed to cover the whole allodynic area without exceeding 40 injection sites. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any pain caused by the injections.

Treatment:

Drug: Normal Saline for Injection