BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy (SPRINT)

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of BG00010 (Neublastin) in Subjects With Painful Lumbar Radiculopathy

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.

Study Overview

• Status: Completed
• Conditions: Sciatica; Radiculopathy; Painful Lumbar Radiculopathy
• Intervention / Treatment: Drug: BG00010; Drug: Placebo

Detailed Description

During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Research Site
  • California
    • Fresno, California, United States, 93710
      • Research Site
    • Lomita, California, United States, 90717
      • Research Site
    • Long Beach, California, United States, 90806
      • Research Site
    • Pasadena, California, United States, 91105
      • Research Site
  • Florida
    • Ft. Lauderdale, Florida, United States, 33312
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
    • Sarasota, Florida, United States, 34232
      • Research Site
    • St. Petersburg, Florida, United States, 33713
      • Research Site
    • Sunrise, Florida, United States, 33351
      • Research Site
    • Tampa, Florida, United States, 33606
      • Research Site
    • Winter Park, Florida, United States, 32789
      • Research Site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Research Site
    • Savannah, Georgia, United States, 31406
      • Research Site
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Research Site
    • Chicago, Illinois, United States, 60657
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Research Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Research Site
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68521
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Research Site
  • Texas
    • San Antonio, Texas, United States, 78731
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BG00010; Administered as an IV injection at various dose levels 3 times per week for 1 week	Drug: BG00010; As specified in the treatment arm; Other Names: Neublastin
Placebo Comparator: Placebo; Matched placebo IV injection 3 times per week for 1 week	Drug: Placebo; As specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score	At the end of treatment period (Day 6-10)

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Maximum observed serum concentration (Cmax) of BG00010	Up to Day 5
Number of participants experiencing adverse events (AEs)	Up to week 9
Number of participants experiencing serious adverse events (SAEs)	Up to week 9
Change from Baseline in Incidence of neutralizing antibodies in serum	Up to week 9

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica; Radiculopathy; Pain
• Other Study ID Numbers: 103NS201