NCT01873404

BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

Conditions

• Painful Lumbar Radiculopathy
• Sciatica
• Radiculopathy

Interventions

Type	Name	Description
DRUG	BG00010	As specified in the treatment arm
DRUG	Placebo	As specified in the treatment arm

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-06-10
• Last updated: 2015-09-10

Locations

25 sites across 1 country: United States