Research Site
Leiden, Netherlands
NCT Number: NCT01405833
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 1
Leiden, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Multiple doses, weight-based IV administration
Single dose IV matched placebo
Time frame: Throughout the study period- an expected 15 weeks
Time frame: Throughout the study period- an expected 15 weeks
Time frame: Throughout the study period- an expected 15 weeks
Assessment of study-treatment-specific safety of BG00010
Time frame: Every day for 3 consecutive days prior to baseline throughout the study period
Time frame: Throughout the study period at each visit
Biogen
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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