Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
|ClinicalTrials.gov Identifier: NCT01405833|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : September 9, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Sciatica||Drug: BG00010 (Neublastin) Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Subjects With Sciatica|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: BG00010 (Neublastin)
Participants may be randomized to escalating doses of BG00010
Drug: BG00010 (Neublastin)
Multiple doses, weight-based IV administration
Placebo Comparator: Placebo
Participants may be randomised to a matching placebo
Single dose IV matched placebo
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405833
|Study Director:||Medical Director||Biogen|