Status:
COMPLETED
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Lead Sponsor:
Biogen
Conditions:
Sciatica
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.
Eligibility Criteria
Inclusion
- Key
- Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.
- Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.
- 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 significant (as determined by the Investigator) allergies, 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 signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.
- History of severe allergic or anaphylactic drug-related reactions. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00961766
Start Date
August 1 2009
End Date
February 1 2012
Last Update
October 28 2014
Active Locations (1)
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1
Research Site
Adelaide, South Australia, Australia, 5000