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

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ClinicalTrials.gov Identifier: NCT01405833
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Sciatica Drug: BG00010 (Neublastin) Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BG00010 (Neublastin)
Participants may be randomized to escalating doses of BG00010
Drug: BG00010 (Neublastin)
Multiple doses, weight-based IV administration
Placebo Comparator: Placebo
Participants may be randomised to a matching placebo
Drug: Placebo
Single dose IV matched placebo

Primary Outcome Measures :
  1. Number of Participants experiencing Adverse Events [ Time Frame: Throughout the study period- an expected 15 weeks ]
  2. Serum drug concentrations of BG00010 as a measure of pharmacokinetics [ Time Frame: Throughout the study period- an expected 15 weeks ]

Secondary Outcome Measures :
  1. Presence of anti-BG00010 antibodies in serum [ Time Frame: Throughout the study period- an expected 15 weeks ]
    Assessment of study-treatment-specific safety of BG00010

  2. Change in pain as measured by Likert numerical pain rating scale [ Time Frame: Every day for 3 consecutive days prior to baseline throughout the study period ]
  3. Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Throughout the study period at each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405833

Research Site
Leiden, Netherlands
Sponsors and Collaborators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01405833     History of Changes
Other Study ID Numbers: 103NS102
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms