Clinical trial NCT00961766: Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Official title: Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sciatica
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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/Exclusion criteria may apply

Primary outcomes:
measure: Number of participants experiencing Adverse Events (AEs)
timeFrame: Up to 56 days post dosing
measure: Change in Likert numerical pain rating scale
timeFrame: Up to 56 days post dosing
measure: Change in Quantitative Sensory Test (QST)
timeFrame: Up to 28 days post dosing
measure: Change in Intra Epidermal Nerve Fiber Density (IENFD)
timeFrame: Up to 28 days post dosing
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 5 days post dosing
measure: Area under the serum concentration curve (AUC)
timeFrame: Up to 5 days post dosing
measure: Terminal half-life (t1/2)
timeFrame: Up to 5 days post dosing
measure: Total body clearance (CL)
timeFrame: Up to 5 days post dosing
measure: Steady state volume of distribution (Vss)
timeFrame: Up to 5 days post dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rolan PE, O'Neill G, Versage E, Rana J, Tang Y, Galluppi G, Aycardi E. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica. PLoS One. 2015 May 11;10(5):e0125034. doi: 10.1371/journal.pone.0125034. eCollection 2015.