BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
NCT ID: NCT01873404
Last Updated: 2015-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2013-06-30
2015-03-31
Brief Summary
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The secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BG00010
Administered as an IV injection at various dose levels 3 times per week for 1 week
BG00010
As specified in the treatment arm
Placebo
Matched placebo IV injection 3 times per week for 1 week
Placebo
As specified in the treatment arm
Interventions
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BG00010
As specified in the treatment arm
Placebo
As specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization.
* Objective, documented evidence of painful lumbar radiculopathy involvement
* Lower back pain
* Leg pain
* Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
Exclusion Criteria
* Clinically significant diseases or conditions as determined by the investigator.
* Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.
* Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).
* Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Fresno, California, United States
Research Site
Lomita, California, United States
Research Site
Long Beach, California, United States
Research Site
Pasadena, California, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Sunrise, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Columbus, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Bloomington, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Evansville, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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103NS201
Identifier Type: -
Identifier Source: org_study_id
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