Clinical Trial: Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010
Brief Summary: The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.
Detailed Summary:
Sponsor: Biogen
Current Primary Outcome:
- Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 56 days post dosing ]
- Change in Likert numerical pain rating scale [ Time Frame: Up to 56 days post dosing ]
- Change in Quantitative Sensory Test (QST) [ Time Frame: Up to 28 days post dosing ]QST; Vibratory, Cool Thermal,
- Change in Intra Epidermal Nerve Fiber Density (IENFD) [ Time Frame: Up to 28 days post dosing ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 5 days post dosing ]
- Area under the serum concentration curve (AUC) [ Time Frame: Up to 5 days post dosing ]
- Terminal half-life (t1/2) [ Time Frame: Up to 5 days post dosing ]
- Total body clearance (CL) [ Time Frame: Up to 5 days post dosing ]
- Steady state volume of distribution (Vss) [ Time Frame: Up to 5 days post dosing ]
Original Primary Outcome: Clinical Laboratory Values, Antibodies, Pharmacokinetics & Adverse Events [ Time Frame: All Visits ]
Current Secondary Outcome:
Original Secondary Outcome: Subject Assessments (Likert Scale, VAS, QST & IENFD) [ Time Frame: Subject completes the different assessments at various times during the study. ]
Information By: Biogen
Dates:
Date Received: August 17, 2009
Date Started: August 2009
Date Completion:
Last Updated: October 24, 2014
Last Verified: October 2014
