Sciatica
Conditions
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.
Interventions
Single dose, weight-based IV administration
DRUGPlacebo
Single dose IV matched placebo
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) | Up to 56 days post dosing | — |
| Change in Likert numerical pain rating scale | Up to 56 days post dosing | — |
| Change in Quantitative Sensory Test (QST) | Up to 28 days post dosing | QST; Vibratory, Cool Thermal, |
| Change in Intra Epidermal Nerve Fiber Density (IENFD) | Up to 28 days post dosing | — |
| Maximum observed serum concentration (Cmax) | Up to 5 days post dosing | — |
| Area under the serum concentration curve (AUC) | Up to 5 days post dosing | — |
| Terminal half-life (t1/2) | Up to 5 days post dosing | — |
| Total body clearance (CL) | Up to 5 days post dosing | — |
| Steady state volume of distribution (Vss) | Up to 5 days post dosing | — |
Countries
Australia
Outcome results
None listed