Status:
TERMINATED
Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Lead Sponsor:
Yale University
Collaborating Sponsors:
Ipsen
Conditions:
Lower Back Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 Dys...
Detailed Description
This is an investigator initiated, randomized, double blind, placebo-controlled study. A total of 90 patients will be enrolled in the study. The study will be conducted over 4 months. It includes 4 vi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02221648
Start Date
December 1 2012
End Date
September 1 2015
Last Update
July 20 2016
Active Locations (1)
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1
Yale Medical Group
New Haven, Connecticut, United States, 06520