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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
183
Research Site
Phoenix, Arizona, United States
Research Site
Fresno, California, United States
Research Site
Lomita, California, United States
Research Site
Long Beach, California, United States
Research Site
Pasadena, California, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Sunrise, Florida, United States
...and 15 more locations
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
Time frame: At the end of treatment period (Day 6-10)
Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score
Time frame: At the end of the treatment period (day 6-10)
Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)
Time frame: At the end of the treatment period (day 6-10)
Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)
Time frame: Up to week 5
Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)
Time frame: Up to week 5
Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)
Time frame: Up to week 5
Maximum observed serum concentration (Cmax) of BG00010
Time frame: Up to Day 5
Number of participants experiencing adverse events (AEs)
Time frame: Up to week 9
Number of participants experiencing serious adverse events (SAEs)
Time frame: Up to week 9
Change from Baseline in Incidence of neutralizing antibodies in serum
Time frame: Up to week 9
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