Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury

NCT02736890 | Terminated Phase 2 Results

• 1 other identifier: GCO 14-2212
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with nerve pain. The researchers propose a double blinded placebo controlled crossover study to study the effects of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord injury.

Conditions

Neuropathic Back Pain; Spinal Cord Injury

Keywords

Botulinum Toxin A; Neuropathic pain; Spinal cord injury; Pain management; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  Participant rated pain intensity from 0-10, with higher score indicating more pain

  up to 12 weeks post-injection, for a total of 24 weeks from baseline

Secondary Outcomes (7)

• 7-Point Guy/Farrar Patient Global Impression of Change (PGIC)

  up to 12 weeks post-injection, for a total of 24 weeks from baseline

• International Basic Pain Dataset - Pain Affecting Day-to-day Activities

  up to 12 weeks post-injection, for a total of 24 weeks from baseline

• International Basic Pain Dataset - Pain Affecting Mood

  up to 12 weeks post-injection, for a total of 24 weeks from baseline

• International Basic Pain Dataset - Pain Affecting Sleep

  up to 12 weeks post-injection, for a total of 24 weeks from baseline

• Static Mechanical Allodynia Testing

  up to 12 weeks post-injection, for a total of 24 weeks from baseline

Study Arms (2)

Botulinum Toxin A

ACTIVE COMPARATOR

Each vial of botulin toxin (100U, BOTOX, Allergan) will be reconstituted with 4ml non-preserved saline solution (0.9%) as recommended by the manufacturer (concentration of 5 units Botulinum Toxin A/0.2ml). Each injection will be 0.2mL (BOTOX, 5 units), administered through a 25 gauge needle. The marked area will have subcutaneous injections, each separated by a radius of 1 cm, from the other injections into the marked area,(maximum of 80 injections, 400 Units).

Drug: Botulinum Toxin A

Placebo

PLACEBO COMPARATOR

Placebo consists of 0.9% normal saline. Each injection will be 0.2mL, administered with a 25 gauge needle subcutaneously into the affected area. The marked area will have subcutaneous injections (maximum of 80) each separated from the surrounding ones by a radius of 1 cm.

Drug: Placebo

Interventions

Botulinum Toxin A DRUG

Subjects will receive subcutaneous Botulinum Toxin A injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.

Also known as: Botox

Botulinum Toxin A

Placebo DRUG

Subjects will receive subcutaneous placebo injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 80 years old
• Diagnosed with traumatic spinal cord injury
• Target pain is considered by the physician as at-level SCI in nature to a high degree of certainty (4 or 5 using a Likert confidence scale ranging from 0-5 where 0 is "purely a guess" and 5 is "absolutely certain")
• Able to give written informed consent
• Target pain that has been continuously present for at least one month
• Target pain is of at least moderate average intensity over the past week, e.g., greater than or equal to 4/10 on a numeric rating scale, the cutoff point for moderate pain in an SCI population.
• Target pain is localized within the dermatome which identifies the NLI or within 3 levels below the NLI
• Subject has been on a stable dose of analgesic mediation (or not on analgesic medication) for at least 3 weeks and is agreeable to remaining on current regimen for the duration of the study (previous prescribed breakthrough analgesics will be allowed)

You may not qualify if:

• Pregnancy
• History of intolerance, hypersensitivity or known allergy to botulinum toxin or its preservatives
• History of intolerance, hypersensitivity or known allergy to EMLA cream (lignocaine/prilocaine eutectic mixture) which is used as an analgesic during BoNT injection
• Recent history of administration of botulinum toxin (within previous 6 months)
• Contraindications to botulinum toxin (myasthenia gravis or other disease of the neuromuscular junction)
• Coagulation disorder
• Current infection
• Insufficient command of English to complete self-report instruments.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

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MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Agnosia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

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

Limitations and Caveats

Target number of participants needed to achieve target power and statistically reliable results not reached. Unsuccessful questionnaires post injection

Results Point of Contact

• Title: Dr. Thomas Bryce
• Organization: Icahn School of Medicine at Mount Sinai

thomas.bryce@mountsinai.org

212-241-6321

Study Officials

• Thomas Bryce, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation Medicine

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)