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CompletedNCT01405833Updated Sep 9, 2014

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

A Phase 1 interventional study of BG00010 (Neublastin) and Placebo in Sciatica, sponsored by Biogen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-09-09.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sciatica

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03

In context

Sciatica

143 studies on the registry are indexed under Sciatica; 29 are open to participants now.

This study's enrollment of 56 is below the median of 66 across 114 interventional studies indexed under Sciatica.

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Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    BG00010 (Neublastin)

    Participants may be randomized to escalating doses of BG00010

    Drug: BG00010 (Neublastin)

  • Placebo comparator
    Placebo

    Participants may be randomised to a matching placebo

    Drug: Placebo

Interventions

  • DrugBG00010 (Neublastin)

    Multiple doses, weight-based IV administration

  • DrugPlacebo

    Single dose IV matched placebo

06

What researchers measure

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

    Assessment of study-treatment-specific safety of BG00010

    Time frame: Throughout the study period- an expected 15 weeks

  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

07

Study locations

1 site
  • Research Site
    Leiden, Netherlands
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2011
First posted
Jul 29, 2011
Start
Jul 2011
Primary completionActual
Sep 2012
CompletionActual
Sep 2012
Last update
Sep 9, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01405833
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Jul 29, 2011
Start date
Jul 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Sep 9, 2014

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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