Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Phase 1
Completed
- Conditions
- Sciatica
- Interventions
- Drug: BG00010 (Neublastin)Drug: Placebo
- Registration Number
- NCT00961766
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BG00010 (Neublastin) BG00010 (Neublastin) Participants may be randomized to escalating doses of BG00010 or matching placebo Placebo Placebo Participants may be randomized to escalating doses of BG00010 or matching placebo
- Primary Outcome Measures
Name Time Method 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 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,
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇦🇺Adelaide, South Australia, Australia