Clinical Trial: Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 S
Brief 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.
Detailed Summary:
Sponsor: Biogen
Current Primary Outcome:
- Number of Participants experiencing Adverse Events [ Time Frame: Throughout the study period- an expected 15 weeks ]
- Serum drug concentrations of BG00010 as a measure of pharmacokinetics [ Time Frame: Throughout the study period- an expected 15 weeks ]
Original Primary Outcome:
- Number of Participants with Adverse Events as a measure of safety and tolerability [ Time Frame: Participants will be followed for the duration of the study; an expected 15 weeks ]
- Serum Concentrations of BG00010 as a measure of Pharmacokinetics [ Time Frame: Participants will be followed for the duration of the study; an expected 15 weeks ]
Current Secondary Outcome:
- Presence of anti-BG00010 antibodies in serum [ Time Frame: Throughout the study period- an expected 15 weeks ]Assessment of study-treatment-specific safety of BG00010
- Change in pain as measured by Likert numerical pain rating scale [ Time Frame: Every day for 3 consecutive days prior to baseline throughout the study period ]
- Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Throughout the study period at each visit ]
Original Secondary Outcome:
Information By: Biogen
Dates:
Date Received: July 21, 2011
Date Started: July 2011
Date Completion:
Last Updated: September 5, 2014
Last Verified: September 2014