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

Primary Purpose

Neuropathic Pain, Allodynia

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Normal Saline for Injection
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • WRHA Health Sciences Centre Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1: Botulinum Toxin Type A

Arm 2: Normal Saline for Injection

Arm 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.

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.

Outcomes

Primary Outcome Measures

Brief Pain Inventory
The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable

Secondary Outcome Measures

Neuropathic Pain Symptom Inventory
This scale rates the mean intensity of 10 neuropathic pain symptoms and their combination into 5 distinct dimensions during the last 24 hours on an 11-point (0-10) numerical scale
The Hospital Anxiety and Depression Scale
14 items scored as anxiety and depression
Daily Sleep Interference Scale
Asks if pain interfered with sleep in the past 24 hours,using an 11-point scale (O-pain did not interfere with sleep, 10-pain completely interfered with sleep). Dispensed at baseline.
Clinician Global Impression Scale
Assesses the clinician's impression of Efficacy and Tolerability of study medication using a 4-point scale, with 1 being Very good, and 4 being Poor
Patient's Global Impression Scale
Measures the patients global impression of the efficacy and tolerability of the study medication on a 4-point scale, with 1 representing very good, and 4 representing poor

Full Information

First Posted
July 25, 2013
Last Updated
October 1, 2015
Sponsor
University of Manitoba
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01911377
Brief Title
Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS
Official Title
The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Allodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Botulinum Toxin Type A
Arm Type
Active Comparator
Arm 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.
Arm Title
Arm 2: Normal Saline for Injection
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Intervention Type
Drug
Intervention Name(s)
Normal Saline for Injection
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable
Time Frame
Baseline and daily until study completion at 13 weeks
Secondary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory
Description
This scale rates the mean intensity of 10 neuropathic pain symptoms and their combination into 5 distinct dimensions during the last 24 hours on an 11-point (0-10) numerical scale
Time Frame
Baseline and follow-up visits(at weeks 1, 4, 8 and 13)
Title
The Hospital Anxiety and Depression Scale
Description
14 items scored as anxiety and depression
Time Frame
Baseline and follow-up visits (at weeks 1, 4, 8 and 13).
Title
Daily Sleep Interference Scale
Description
Asks if pain interfered with sleep in the past 24 hours,using an 11-point scale (O-pain did not interfere with sleep, 10-pain completely interfered with sleep). Dispensed at baseline.
Time Frame
Baseline and daily during study period until week 13.
Title
Clinician Global Impression Scale
Description
Assesses the clinician's impression of Efficacy and Tolerability of study medication using a 4-point scale, with 1 being Very good, and 4 being Poor
Time Frame
Final visit at week 13
Title
Patient's Global Impression Scale
Description
Measures the patients global impression of the efficacy and tolerability of the study medication on a 4-point scale, with 1 representing very good, and 4 representing poor
Time Frame
Final visit at week 13
Other Pre-specified Outcome Measures:
Title
Measurement of brush-induced allodynia
Description
The area of skin with allodynic pain is stroked with a standardized brush and the patient reports any pain associated with the stroking.
Time Frame
Baseline and follow-up visits(weeks 1, 4, 8 and 13)
Title
Measurement of mechanical sensations and pain thresholds
Description
An algometer (a device that pushes against the skin to measure when pain is felt) will be used on the allodynic area
Time Frame
Baseline and follow-up visits (weeks 1, 4 , 8 and 13)
Title
Recording Area of allodynia
Description
The area of allodynic pain to be treated is traced on transparent paper
Time Frame
Baseline and follow-up visits (at weeks 1, 4, 8 and 13)
Title
Measurement of temperature sensations and pain thresholds
Description
A thermo-test is used to measure temperature sensations and pain thresholds in the allodynic area
Time Frame
Baseline and follow-up visits(at weeks 1, 4, 8 and 13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ethans, MD
Organizational Affiliation
Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
WRHA Health Sciences Centre Rehabilitation Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A IM4
Country
Canada

12. IPD Sharing Statement

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

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