Sciatica Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of BG00010 (Neublastin) in Subjects With Painful Lumbar Radiculopathy
The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010
(Neublastin) in improving pain in painful lumbar radiculopathy participants when
administered 3 times per week for 1 week.
The secondary objectives of this study in this study population are as follows: To explore
the duration of the effect of BG00010 in improving pain; To explore the dose response curve
on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum
exposure to BG00010.
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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