Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain

NCT02221648 | Terminated Phase 2 Results

• 1 other identifier: 1210011010
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain. The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.

Conditions

Lower Back Pain

Keywords

Back; Pain; Muscle

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)

  The primary outcome measure in this protocol is the proportion of subjects that have VAS \<4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).

  6 weeks

Secondary Outcomes (2)

• Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)

  6 weeks

• Number of Subjects Showing Improvement on Quality of Life Scale for Pain

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.

Drug: Placebo

AbobotulinumtoxinA Treatment

ACTIVE COMPARATOR

Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.

Drug: AbobotulinumtoxinA Treatment

Interventions

Placebo DRUG

Subjects will be randomization to receive either the study drug or the placebo group.

Placebo

AbobotulinumtoxinA Treatment DRUG

Subjects receive intervention injections with the study drug arbobotulinumtoxinA.

Also known as: Dysport

AbobotulinumtoxinA Treatment

Eligibility Criteria

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

You may qualify if:

• Age 18-80, all ethnic groups, races, both sexes.
• Diagnosis of chronic low back pain (longer than 3 months).
• Pain of moderate to severe intensity (VAS 4 or higher).
• Subjects who are able to read, speak, and understand English.

You may not qualify if:

• Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
• Hypersensitivity to any botulinum toxin product or is recipient
• Allergy to albumin. Lactose or cow milk protein
• Infection in the proposed injection site.
• Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
• Active breast feeding.
• Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
• Patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction (anticholinergics , muscle relaxants)
• Subjects who are younger than 18 years of age.
• Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral Sclerosis.
• Evidence of acute pathology on neuro-imaging.
• Axis I diagnosis determined by a neurologist or psychiatrist.
• Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
• Received botulinum toxin injections in the past 3 months.
• History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI

Sponsors & Collaborators

• Yale University: lead
• Ipsen: collaborator

Study Sites (1)

Yale Medical Group

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated due to relocation of the PI. The initial goal was enrolling 90 patients. The number enrolled at the time of termination was 43, with 37 completed the study. Results may not provide enough statistical power.

Results Point of Contact

• Title: Bahman Jabbari M.D, , Professor of Neurology
• Organization: Yale University School of Medicine

bahman.jabbari@yale.edu

203-737-2464

Study Officials

• Bahman Jabbari, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: August 20, 2014
• Study Start: December 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 20, 2016
• Results First Posted: March 8, 2016

Record last verified: 2016-07

Locations

US (1)