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The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG00010 (Neublastin) | Experimental | Participants may be randomized to escalating doses of BG00010 or matching placebo |
|
| Placebo | Placebo Comparator | Participants may be randomized to escalating doses of BG00010 or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00010 (Neublastin) | Drug | Single dose, weight-based IV administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) | Up to 56 days post dosing | |
| Change in Likert numerical pain rating scale | Up to 56 days post dosing | |
| Change in Quantitative Sensory Test (QST) | QST; Vibratory, Cool Thermal, | Up to 28 days post dosing |
| Change in Intra Epidermal Nerve Fiber Density (IENFD) | Up to 28 days post dosing | |
| Maximum observed serum concentration (Cmax) | Up to 5 days post dosing | |
| Area under the serum concentration curve (AUC) | Up to 5 days post dosing | |
| Terminal half-life (t1/2) | Up to 5 days post dosing | |
| Total body clearance (CL) | Up to 5 days post dosing | |
| Steady state volume of distribution (Vss) | Up to 5 days post dosing |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Adelaide | South Australia | 5000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25962165 | Derived | Rolan PE, O'Neill G, Versage E, Rana J, Tang Y, Galluppi G, Aycardi E. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica. PLoS One. 2015 May 11;10(5):e0125034. doi: 10.1371/journal.pone.0125034. eCollection 2015. |
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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 |
|
| 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 |