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Dysport in Chronic Low Back Pain
NCT02221648Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2012
- Primary completion
- Sep 2015
- Countries
- 1
- Sponsor
- Yale University
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- chronic low back pain (CLBP)
01
Overview
Phase 2, randomised, double-blind trial in chronic low back pain (CLBP) comparing Placebo with Dysport (2 arms). Primary endpoint: Proportion of Participants With Mild or no Pain on Visual Analog Scale at 6 weeks. Started Dec 2012; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Normal saline injection
Dysport
AbobotulinumtoxinA injection (500-1000 units)
03
Who it enrols
Adult patients with chronic low back pain (>3 months) of moderate to severe intensity (VAS >= 4), excluding those with specific medical conditions, recent back surgery, or recent use of interfering medications.
04
Endpoints
Primary
Proportion of Participants With Mild or no Pain on Visual Analog Scale
Secondary
Patient Global Impression of Change
Quality of Life Scale for Pain
05
Results
Not all primary endpoints met
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