Sciatica
Conditions
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 frequently as every 48 hours (but no more than 3 times per week). Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
Interventions
Multiple doses, weight-based IV administration
DRUGPlacebo
Single dose IV matched placebo
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants experiencing Adverse Events | Throughout the study period- an expected 15 weeks |
| Serum drug concentrations of BG00010 as a measure of pharmacokinetics | Throughout the study period- an expected 15 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of anti-BG00010 antibodies in serum | Throughout the study period- an expected 15 weeks | Assessment of study-treatment-specific safety of BG00010 |
| Change in pain as measured by Likert numerical pain rating scale | Every day for 3 consecutive days prior to baseline throughout the study period | — |
| Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) | Throughout the study period at each visit | — |
Countries
Netherlands
Outcome results
None listed