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

NCT02221648 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-07-20

Study results available
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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

Interventions

DRUG

Placebo

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

DRUG

AbobotulinumtoxinA Treatment

Subjects receive intervention injections with the study drug arbobotulinumtoxinA.

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Bahman Jabbari, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02221648 on ClinicalTrials.gov