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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.
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG00010 | Experimental | Administered as an IV injection at various dose levels 3 times per week for 1 week |
|
| Placebo | Placebo Comparator | Matched placebo IV injection 3 times per week for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00010 | Drug | As specified in the treatment arm |
|
|
| 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) |
| 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) |
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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 | Phoenix | Arizona | 85018 | United States | ||
| Research Site |
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| Placebo | Drug | As specified in the treatment arm |
|
| 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 |
| Fresno |
| California |
| 93710 |
| United States |
| Research Site | Lomita | California | 90717 | United States |
| Research Site | Long Beach | California | 90806 | United States |
| Research Site | Pasadena | California | 91105 | United States |
| Research Site | Fort Lauderdale | Florida | 33312 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Sarasota | Florida | 34232 | United States |
| Research Site | St. Petersburg | Florida | 33713 | United States |
| Research Site | Sunrise | Florida | 33351 | United States |
| Research Site | Tampa | Florida | 33606 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Columbus | Georgia | 31904 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Bloomington | Illinois | 61701 | United States |
| Research Site | Chicago | Illinois | 60657 | United States |
| Research Site | Evansville | Indiana | 47714 | United States |
| Research Site | Overland Park | Kansas | 66210 | United States |
| Research Site | Brockton | Massachusetts | 02301 | United States |
| Research Site | Lincoln | Nebraska | 68521 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | San Antonio | Texas | 78731 | United States |
| Research Site | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| D012585 | Sciatica |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C490886 | ARTN protein, human |
| D020932 | Nerve Growth Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |
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