Status:
COMPLETED
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
Lead Sponsor:
Biogen
Conditions:
Sciatica
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequ...
Eligibility Criteria
Inclusion
- Key
- Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
- Must rate their pain at \>/=40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.
- Key
Exclusion
- History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
- Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
- Current generalized myalgia
- Serum creatinine \>1.5 x upper limit of normal (ULN).
- History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
- Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01405833
Start Date
July 1 2011
End Date
September 1 2012
Last Update
September 9 2014
Active Locations (1)
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1
Research Site
Leiden, Netherlands