low back pain sciatica
Conditions
Interventions
4 ascending IV doses will be examined (50, 150, 400, and 800 µg/kg). Dose
escalation will first occur in Part I (the once weekly group). Once escalation
is complete up to 800 µg/kg, or a maximum tol
Sponsors
Biogen Idec Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information). 2. Must be aged 18 to 85 years old, inclusive, at the time of informed consent. 3. Must have a diagnosis of unilateral sciatica, determined by the Investigator including pain radiating down the leg following a dermatome, suggesting L4, L5, or S1 nerve root involvement. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit. 4. Must rate their pain at >=40 mm on the 100 mm VAS of the SF-MPQ at the Screening and Baseline Visits. 5. All male subjects and all female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 2 months after their last dose of study treatment.
Exclusion criteria
Exclusion criteria: Medical History 1. History of malignancy or clinically relevant (as determined by the Investigator) 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. 2. History of severe pain as judged by the investigator, other than that caused by sciatica, during the 3 months prior to their screening visit 3. Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to screening 4. History of severe allergic or anaphylactic drug-related reactions. 5. Major surgery within the 3 months prior to the Screening Visit or planned sciatica surgery within 6 months of the Screening Visit. 6. Current generalized myalgia. 7. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to the Baseline Visit. 8. Laboratory value at the Screening or Baseline Visits that is outside the normal range, unless it is judged by the Investigator as not clinically relevant after appropriate evaluation. 9. Serum Creatinine clearance >1.5 x upper limit of normal (ULN). 10. History of or positive screening test for hepatitis C infection (defined as positive for hepatitis C virus antibody [HCVAb]), hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or positive for hepatitis B core antibody [HBcAb] at Screening), 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; Appendix 28). 11. Clinically relevant abnormal electrocardiogram (ECG, 12-lead) at the Screening or Baseline Visits, as determined by the Investigator. Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at the Screening or Baseline Visits will not be allowed to enroll into the study.;Treatment History 12. Previous participation in a study with neurotrophic factors. 13. Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit. 14. Any immunization/vaccination within 1 month prior to the Baseline Visit. 15. Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stabilized prior to the Baseline Visit. Selective serotonin reuptake inhibitor, selective noradrenaline reuptake inhibitor, and tricyclic antidepressant doses must be stable for 4 weeks prior to the Baseline Visit. Gabapentin and pregabalin doses must be stable for 1 week prior to the Baseline Visit. ;Miscellaneous 16. Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits. 17. Relevant history of illicit drug or alcohol abuse (as determined by the Investigator) within 1 year of the Screening Visit. Subjects who have a positive urine drug test at the Screening or Baseline Visits may be enrolled at the discretion of the Investigator. 18. Blood donation (1 unit or more) within 1 month prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: -the number and proportion of subjects with Adverse Events (AEs) -the type and severity of AEs -changes in clinical laboratory measurements -pharmacokinetic (PK) parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: -the incidence of anti-BG00010 antibodies -changes in pain as measured by a Likert numerical pain rating scale and the VAS of the SF-MPQ Exploratory endpoints: -Intra Epidermal Nerve Fiber Density (IENFD) in both affected and unaffected leg to assess for change -changes in pain thresholds as determined by longitudinal nociceptive testing (electrical and mechanical pain, and cold pressor testing) | — |
Countries
Netherlands
Outcome results
None listed