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

This study has been completed.
Information provided by (Responsible Party):
Biogen Identifier:
First received: May 7, 2013
Last updated: August 27, 2015
Last verified: April 2015

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.

Condition Intervention Phase
Painful Lumbar Radiculopathy
Drug: BG00010
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

Further study details as provided by Biogen:

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 ]

Enrollment: 183
Study Start Date: June 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Neublastin
Placebo Comparator: Placebo
Matched placebo IV injection 3 times per week for 1 week
Drug: Placebo
As specified in the treatment arm

Detailed Description:

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


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

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
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Please refer to this study by its identifier: NCT01873404

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Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen Identifier: NCT01873404     History of Changes
Other Study ID Numbers: 103NS201
Study First Received: May 7, 2013
Last Updated: August 27, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms processed this record on October 06, 2015