Back to resultsBG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy (SPRINT)
Primary Purpose
Painful Lumbar Radiculopathy, Sciatica, Radiculopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BG00010
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Painful Lumbar Radiculopathy
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BG00010
Placebo
Arm Description
Administered as an IV injection at various dose levels 3 times per week for 1 week
Matched placebo IV injection 3 times per week for 1 week
Outcomes
Primary Outcome Measures
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
Secondary Outcome Measures
Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score
Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)
Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)
Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)
Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)
Maximum observed serum concentration (Cmax) of BG00010
Number of participants experiencing adverse events (AEs)
Number of participants experiencing serious adverse events (SAEs)
Change from Baseline in Incidence of neutralizing antibodies in serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01873404
Brief Title
BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
Acronym
SPRINT
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Lumbar Radiculopathy, Sciatica, Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG00010
Arm Type
Experimental
Arm Description
Administered as an IV injection at various dose levels 3 times per week for 1 week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo IV injection 3 times per week for 1 week
Intervention Type
Drug
Intervention Name(s)
BG00010
Other Intervention Name(s)
Neublastin
Intervention Description
As specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
As specified in the treatment arm
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)
Time Frame
Up to week 5
Title
Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)
Time Frame
Up to week 5
Title
Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)
Time Frame
Up to week 5
Title
Maximum observed serum concentration (Cmax) of BG00010
Time Frame
Up to Day 5
Title
Number of participants experiencing adverse events (AEs)
Time Frame
Up to week 9
Title
Number of participants experiencing serious adverse events (SAEs)
Time Frame
Up to week 9
Title
Change from Baseline in Incidence of neutralizing antibodies in serum
Time Frame
Up to week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Research Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Research Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Research Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Research Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Research Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68521
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
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BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
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