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

NCT01911377 | Terminated Phase 2

• 1 other identifier: Botox 2013
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Neuropathic Pain Symptom Inventory

  Baseline and follow-up visits(at weeks 1, 4, 8 and 13)

• The Hospital Anxiety and Depression Scale

  Baseline and follow-up visits (at weeks 1, 4, 8 and 13).

• Daily Sleep Interference Scale

  Baseline and daily during study period until week 13.

• Clinician Global Impression Scale

  Final visit at week 13

• Patient's Global Impression Scale

  Final visit at week 13

Other Outcomes (4)

• Measurement of brush-induced allodynia

  Baseline and follow-up visits(weeks 1, 4, 8 and 13)

• Measurement of mechanical sensations and pain thresholds

  Baseline and follow-up visits (weeks 1, 4 , 8 and 13)

• Recording Area of allodynia

  Baseline and follow-up visits (at weeks 1, 4, 8 and 13)

Study Arms (2)

Arm 1: Botulinum Toxin Type A

ACTIVE COMPARATOR

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.

Drug: Botulinum Toxin Type A

Arm 2: Normal Saline for Injection

PLACEBO COMPARATOR

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.

Drug: Normal Saline for Injection

Interventions

Botulinum Toxin Type A DRUG

Arm 1: Botulinum Toxin Type A

Normal Saline for Injection DRUG

Arm 2: Normal Saline for Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Allergan: collaborator

Study Sites (1)

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A IM4, Canada

Location

MeSH Terms

Conditions

Neuralgia; Hyperalgesia

Interventions

Botulinum Toxins, Type A; Saline Solution; Injections

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Karen Ethans, MD

  Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Cord Injury Rehabilitation Program

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 30, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

CA (1)