Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica

Biogen1 site in 1 country56 target enrollmentJuly 2011

ConditionsSciatica

InterventionsBG00010 (Neublastin)Placebo

Overview

Phase: Phase 1
Intervention: BG00010 (Neublastin)
Conditions: Sciatica
Sponsor: Biogen
Enrollment: 56
Locations: 1
Primary Endpoint: Serum drug concentrations of BG00010 as a measure of pharmacokinetics
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).

Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

September 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
•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.

Exclusion Criteria

•History of malignancy or clinically relevant 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.
•History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
•Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
•Current generalized myalgia
•Serum creatinine \>1.5 x upper limit of normal (ULN).
•History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody 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).
•Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Arms & Interventions

BG00010 (Neublastin)

Participants may be randomized to escalating doses of BG00010

Intervention: BG00010 (Neublastin)

Placebo

Participants may be randomised to a matching placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Serum drug concentrations of BG00010 as a measure of pharmacokinetics

Time Frame: Throughout the study period- an expected 15 weeks

Number of Participants experiencing Adverse Events

Time Frame: Throughout the study period- an expected 15 weeks

Secondary Outcomes

Presence of anti-BG00010 antibodies in serum(Throughout the study period- an expected 15 weeks)
Change in pain as measured by Likert numerical pain rating scale(Every day for 3 consecutive days prior to baseline throughout the study period)
Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)(Throughout the study period at each visit)