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

Biogen

Status and phase: Completed; Phase 1

Conditions: Sciatica

Treatments: Drug: BG00010 (Neublastin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405833

103NS102

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

BG00010 (Neublastin)

Experimental group

Description:

Participants may be randomized to escalating doses of BG00010

Treatment:

Drug: BG00010 (Neublastin)

Placebo

Placebo Comparator group

Description:

Participants may be randomised to a matching placebo

Treatment:

Drug: Placebo