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

NCT01405833 | Completed Phase 1 DMC

• 1 other identifier: 103NS102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Sciatica

Outcome Measures

Primary Outcomes (2)

• Number of Participants experiencing Adverse Events

  Throughout the study period- an expected 15 weeks

• Serum drug concentrations of BG00010 as a measure of pharmacokinetics

  Throughout the study period- an expected 15 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

BG00010 (Neublastin)

EXPERIMENTAL

Participants may be randomized to escalating doses of BG00010

Drug: BG00010 (Neublastin)

Placebo

PLACEBO COMPARATOR

Participants may be randomised to a matching placebo

Drug: Placebo

Interventions

BG00010 (Neublastin) DRUG

Multiple doses, weight-based IV administration

BG00010 (Neublastin)

Placebo DRUG

Single dose IV matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Leiden, Netherlands

Location

MeSH Terms

Conditions

Sciatica

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 29, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

NL (1)