Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.

Phase 1

Completed

• Conditions: Sciatica
• Interventions: Drug: BG00010 (Neublastin); Drug: Placebo

• Registration Number: NCT01405833
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Key

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

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
Placebo	Placebo	Participants may be randomised to a matching placebo

Primary Outcome Measures

Name	Time	Method
Serum drug concentrations of BG00010 as a measure of pharmacokinetics	Throughout the study period- an expected 15 weeks
Number of Participants experiencing Adverse Events	Throughout the study period- an expected 15 weeks

Secondary Outcome Measures

Name	Time	Method
Presence of anti-BG00010 antibodies in serum	Throughout the study period- an expected 15 weeks	Assessment of study-treatment-specific safety of BG00010
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

Trial Locations

Locations (1)

Research Site; 🇳🇱 Leiden, Netherlands