BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy

Launched by BIOGEN · Jun 6, 2013

Keywords

ClinConnect Summary

During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 Criteria:
• • 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