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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01873404
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

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.


Condition or disease Intervention/treatment Phase
Painful Lumbar Radiculopathy Sciatica Radiculopathy Drug: BG00010 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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 Name: Neublastin

Placebo Comparator: Placebo
Matched placebo IV injection 3 times per week for 1 week
Drug: Placebo
As specified in the treatment arm




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI) [ Time Frame: Up to week 5 ]
  4. Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI) [ Time Frame: Up to week 5 ]
  5. Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI) [ Time Frame: Up to week 5 ]
  6. Maximum observed serum concentration (Cmax) of BG00010 [ Time Frame: Up to Day 5 ]
  7. Number of participants experiencing adverse events (AEs) [ Time Frame: Up to week 9 ]
  8. Number of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to week 9 ]
  9. Change from Baseline in Incidence of neutralizing antibodies in serum [ Time Frame: Up to week 9 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873404


Locations
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United States, Arizona
Research Site
Phoenix, Arizona, United States, 85018
United States, California
Research Site
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
United States, Florida
Research Site
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
United States, Georgia
Research Site
Columbus, Georgia, United States, 31904
Research Site
Savannah, Georgia, United States, 31406
United States, Illinois
Research Site
Bloomington, Illinois, United States, 61701
Research Site
Chicago, Illinois, United States, 60657
United States, Indiana
Research Site
Evansville, Indiana, United States, 47714
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Research Site
Brockton, Massachusetts, United States, 02301
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68521
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site
San Antonio, Texas, United States, 78731
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01873404    
Other Study ID Numbers: 103NS201
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Radiculopathy
Sciatica
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Neuralgia