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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG00010 (Neublastin) | Experimental | Participants may be randomized to escalating doses of BG00010 |
|
| Placebo | Placebo Comparator | Participants may be randomised to a matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00010 (Neublastin) | Drug | Multiple doses, weight-based IV administration |
| |
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D020932 | Nerve Growth Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo |
| Drug |
Single dose IV matched placebo |
|
| 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 |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |