Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Sciatica
• Intervention / Treatment: Drug: Placebo; Drug: BG00010 (Neublastin)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BG00010 (Neublastin); Participants may be randomized to escalating doses of BG00010 or matching placebo	Drug: BG00010 (Neublastin); Single dose, weight-based IV administration
Placebo Comparator: Placebo; Participants may be randomized to escalating doses of BG00010 or matching placebo	Drug: Placebo; Single dose IV matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	QST; Vibratory, Cool Thermal,	Up to 28 days post dosing
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

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 17, 2009
• First Submitted That Met QC Criteria: August 18, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica
• Other Study ID Numbers: 103NS101