Status:
COMPLETED
BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
Lead Sponsor:
Biogen
Conditions:
Painful Lumbar Radiculopathy
Sciatica
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
Eligibility Criteria
Inclusion
- Key
- Body weight ≤133 kg.
- Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization.
- Objective, documented evidence of painful lumbar radiculopathy involvement
- Lower back pain
- Leg pain
- Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
- Key
Exclusion
- History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.
- Clinically significant diseases or conditions as determined by the investigator.
- Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.
- Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).
- Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01873404
Start Date
June 1 2013
End Date
March 1 2015
Last Update
September 10 2015
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Phoenix, Arizona, United States, 85018
2
Research Site
Fresno, California, United States, 93710
3
Research Site
Lomita, California, United States, 90717
4
Research Site
Long Beach, California, United States, 90806