BG00010
DrugAs specified in the treatment arm
Other names: Neublastin
NCT Number: NCT01873404
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Research Site, Phoenix, Arizona, United States
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
As specified in the treatment arm
Other names: Neublastin
As specified in the treatment arm
Time frame: At the end of treatment period (Day 6-10)
Time frame: At the end of the treatment period (day 6-10)
Time frame: At the end of the treatment period (day 6-10)
Time frame: Up to week 5
Time frame: Up to week 5
Time frame: Up to week 5
Time frame: Up to Day 5
Time frame: Up to week 9
Time frame: Up to week 9
Time frame: Up to week 9
Biogen
Industry
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
Acronym: SPRINT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01842126
Healthy, Mononeuropathies
Leiden, Netherlands
View Trial DetailsNCT02644421
Mononeuropathies, Nervous System Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT00009672
Back Pain, Low Back Pain
Bethesda, Maryland, United States
View Trial DetailsNCT01495923
Back Pain, Low Back Pain
San Diego, California, United States
View Trial Details