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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01873404
First received: May 7, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.

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


Condition Intervention Phase
Painful Lumbar Radiculopathy
Sciatica
Radiculopathy
Drug: BG00010 (Neublastin)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • change from Baseline in the mean 24-hour average general pain intensity (AGPI) score [ Time Frame: At the end of treatment period (Day 6-10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score [ Time Frame: At the end of the treatment period (day 6-10) ] [ Designated as safety issue: No ]
  • Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI) [ Time Frame: At the end of the treatment period (day 6-10) ] [ Designated as safety issue: No ]
  • Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI) [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
  • Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI) [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
  • Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI) [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) of BG00010 [ Time Frame: Up to Day 5 ] [ Designated as safety issue: No ]
  • Number of participants experiencing adverse events (AEs) [ Time Frame: Up to week 9 ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to week 9 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Incidence of neutralizing antibodies in serum [ Time Frame: Up to week 9 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 165
Study Start Date: June 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00010 (Neublastin)
Administered as an intravenous (IV) injection at various dose levels 3 times per week for 1 week
Drug: BG00010 (Neublastin)
Administered as specified in the treatment arm
Placebo Comparator: Placebo Dose
Matched placebo Intravenous (IV) injection 3 times per week for 1 week
Drug: Placebo
Participants receive matched placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873404

Contacts
Contact: Biogen Idec Investigator clinicaltrials@biogenidec.com

Locations
United States, Arizona
Research Site Recruiting
Phoenix, Arizona, United States, 85018
United States, California
Research Site Recruiting
Fresno, California, United States, 93710
Research Site Recruiting
Long Beach, California, United States, 90806
Research Site Recruiting
Pasadena, California, United States, 91105
United States, Florida
Research Site Recruiting
Hileah, Florida, United States, 33013
Research Site Not yet recruiting
Sarasota, Florida, United States, 32232
United States, Georgia
Research Site Recruiting
Columbus, Georgia, United States, 31904
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60657
United States, Indiana
Research Site Not yet recruiting
Evansville, Indiana, United States, 47714
United States, Kansas
Research Site Recruiting
Overland Park, Kansas, United States, 66210
United States, Kentucky
Research Site Recruiting
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Research Site Not yet recruiting
Boston, Massachusetts, United States, 02135
United States, New York
Research Site Not yet recruiting
Rochester, New York, United States, 14618
United States, North Carolina
Research Site Recruiting
Raleigh, North Carolina, United States, 27612
Research Site Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Research Site Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site Not yet recruiting
Austin, Texas, United States, 78731
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01873404     History of Changes
Other Study ID Numbers: 103NS201
Study First Received: May 7, 2013
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pain
Radiculopathy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 16, 2014