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

NCT ID: NCT01911377

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-08-31

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 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.

Conditions

Neuropathic Pain; Allodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1: Botulinum Toxin Type A

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.

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

Arm 2: Normal Saline for Injection

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline for Injection

Intervention Type: DRUG

Interventions

Botulinum Toxin Type A

Intervention Type: DRUG

Normal Saline for Injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Karen Ethans

Director, Spinal Cord Injury Rehabilitation Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Ethans, MD

Role: PRINCIPAL_INVESTIGATOR

Health Sciences Centre

Locations

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

Botox 2013

Identifier Type: -

Identifier Source: org_study_id