BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy

Study Overview
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Brief Summary
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The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week. The secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.

Detailed Description
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During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

Official Title
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A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of BG00010 (Neublastin) in Subjects With Painful Lumbar Radiculopathy

Conditions
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Painful Lumbar Radiculopathy, Sciatica, Radiculopathy

Intervention / Treatment
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* Drug: BG00010
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Body weight ≤133 kg. Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization. Objective, documented evidence of painful lumbar radiculopathy involvement Lower back pain Leg pain Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. Key Exclusion Criteria: History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection. Clinically significant diseases or conditions as determined by the investigator. Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study. Previous participation in a study with neurotrophic factors (e.g., nerve growth factor). Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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<br>Administered as an IV injection at various dose levels 3 times per week for 1 week | Drug: BG00010<br>* As specified in the treatment arm<br>* Other names: Neublastin;|
| Placebo Comparator: Placebo<br>Matched placebo IV injection 3 times per week for 1 week | Drug: Placebo<br>* As specified in the treatment arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score |  | At the end of treatment period (Day 6-10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score |  | At the end of the treatment period (day 6-10) | 
| Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI) |  | At the end of the treatment period (day 6-10) | 
| Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI) |  | Up to week 5 | 
| Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI) |  | Up to week 5 | 
| Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI) |  | Up to week 5 | 
| Maximum observed serum concentration (Cmax) of BG00010 |  | Up to Day 5 | 
| Number of participants experiencing adverse events (AEs) |  | Up to week 9 | 
| Number of participants experiencing serious adverse events (SAEs) |  | Up to week 9 | 
| Change from Baseline in Incidence of neutralizing antibodies in serum |  | Up to week 9 |