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Completed

NCT Number: NCT01405833

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BG00010 (Neublastin)

Drug

Multiple doses, weight-based IV administration

Placebo

Drug

Single dose IV matched placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2011
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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