Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01873404
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01873404
Study Brief:
Protocol Section:
NCT01873404