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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sciatica

Intervention / Treatment
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* Drug: BG00010 (Neublastin)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit. Must rate their pain at >/=40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits. Key Exclusion Criteria: History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease. History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit. Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit. Current generalized myalgia Serum creatinine >1.5 x upper limit of normal (ULN). History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel). Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BG00010 (Neublastin)<br>Participants may be randomized to escalating doses of BG00010 | Drug: BG00010 (Neublastin)<br>* Multiple doses, weight-based IV administration<br>|
| Placebo Comparator: Placebo<br>Participants may be randomised to a matching placebo | Drug: Placebo<br>* Single dose IV matched placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants experiencing Adverse Events |  | Throughout the study period- an expected 15 weeks | 
| Serum drug concentrations of BG00010 as a measure of pharmacokinetics |  | Throughout the study period- an expected 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of anti-BG00010 antibodies in serum | Assessment of study-treatment-specific safety of BG00010 | Throughout the study period- an expected 15 weeks | 
| Change in pain as measured by Likert numerical pain rating scale |  | 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) |  | Throughout the study period at each visit |