NCT01405833

Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.

Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week). Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.

Conditions

• Sciatica

Interventions

Type	Name	Description
DRUG	BG00010 (Neublastin)	Multiple doses, weight-based IV administration
DRUG	Placebo	Single dose IV matched placebo

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-07-29
• Last updated: 2014-09-09

Locations

1 site across 1 country: Netherlands