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

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01911377
• Other study ID #: Botox 2013
• Status: Terminated
• Phase: Phase 2
• First received: July 25, 2013
• Last updated: October 1, 2015
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allodynia
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Botulinum Toxin Type A

• Normal Saline for Injection

Locations

Country	Name	City	State
Canada	WRHA Health Sciences Centre Rehabilitation Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of brush-induced allodynia	The area of skin with allodynic pain is stroked with a standardized brush and the patient reports any pain associated with the stroking.	Baseline and follow-up visits(weeks 1, 4, 8 and 13)	No
Other	Measurement of mechanical sensations and pain thresholds	An algometer (a device that pushes against the skin to measure when pain is felt) will be used on the allodynic area	Baseline and follow-up visits (weeks 1, 4 , 8 and 13)	No
Other	Recording Area of allodynia	The area of allodynic pain to be treated is traced on transparent paper	Baseline and follow-up visits (at weeks 1, 4, 8 and 13)	No
Other	Measurement of temperature sensations and pain thresholds	A thermo-test is used to measure temperature sensations and pain thresholds in the allodynic area	Baseline and follow-up visits(at weeks 1, 4, 8 and 13)	No
Primary	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	Baseline and daily until study completion at 13 weeks	No
Secondary	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	Baseline and follow-up visits(at weeks 1, 4, 8 and 13)	No
Secondary	The Hospital Anxiety and Depression Scale	14 items scored as anxiety and depression	Baseline and follow-up visits (at weeks 1, 4, 8 and 13).	No
Secondary	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.	Baseline and daily during study period until week 13.	No
Secondary	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	Final visit at week 13	No
Secondary	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	Final visit at week 13	No