NCT01873404

Brief Summary

The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

May 7, 2013

Last Update Submit

August 27, 2015

Conditions

Painful Lumbar RadiculopathySciaticaRadiculopathy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score

    At the end of treatment period (Day 6-10)

Secondary Outcomes (9)

  • Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score

    At the end of the treatment period (day 6-10)

  • Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)

    At the end of the treatment period (day 6-10)

  • Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)

    Up to week 5

  • Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)

    Up to week 5

  • Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)

    Up to week 5

  • +4 more secondary outcomes

Study Arms (2)

BG00010

EXPERIMENTAL

Administered as an IV injection at various dose levels 3 times per week for 1 week

Drug: BG00010

Placebo

PLACEBO COMPARATOR

Matched placebo IV injection 3 times per week for 1 week

Drug: Placebo

Interventions

BG00010DRUG

As specified in the treatment arm

Also known as: Neublastin
BG00010
PlaceboDRUG

As specified in the treatment arm

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body weight ≤133 kg.
  • 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.

You may not qualify if:

  • History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Phoenix, Arizona, 85018, United States

Location

Research Site

Fresno, California, 93710, United States

Location

Research Site

Lomita, California, 90717, United States

Location

Research Site

Long Beach, California, 90806, United States

Location

Research Site

Pasadena, California, 91105, United States

Location

Research Site

Fort Lauderdale, Florida, 33312, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Research Site

Sarasota, Florida, 34232, United States

Location

Research Site

St. Petersburg, Florida, 33713, United States

Location

Research Site

Sunrise, Florida, 33351, United States

Location

Research Site

Tampa, Florida, 33606, United States

Location

Research Site

Winter Park, Florida, 32789, United States

Location

Research Site

Columbus, Georgia, 31904, United States

Location

Research Site

Savannah, Georgia, 31406, United States

Location

Research Site

Bloomington, Illinois, 61701, United States

Location

Research Site

Chicago, Illinois, 60657, United States

Location

Research Site

Evansville, Indiana, 47714, United States

Location

Research Site

Overland Park, Kansas, 66210, United States

Location

Research Site

Brockton, Massachusetts, 02301, United States

Location

Research Site

Lincoln, Nebraska, 68521, United States

Location

Research Site

Raleigh, North Carolina, 27612, United States

Location

Research Site

Winston-Salem, North Carolina, 27103, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

San Antonio, Texas, 78731, United States

Location

Research Site

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

SciaticaRadiculopathy

Interventions

ARTN protein, humanNerve Growth Factor

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

June 10, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-04

Locations

US(25)