Back to resultsStudy of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
Primary Purpose
Sciatica
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
BG00010 (Neublastin)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sciatica
Eligibility Criteria
Key Inclusion Criteria:
- Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
- Must rate their pain at >/=40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.
Key Exclusion Criteria:
- History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
- Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
- Current generalized myalgia
- Serum creatinine >1.5 x upper limit of normal (ULN).
- History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
- Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BG00010 (Neublastin)
Placebo
Arm Description
Participants may be randomized to escalating doses of BG00010
Participants may be randomised to a matching placebo
Outcomes
Primary Outcome Measures
Number of Participants experiencing Adverse Events
Serum drug concentrations of BG00010 as a measure of pharmacokinetics
Secondary Outcome Measures
Presence of anti-BG00010 antibodies in serum
Assessment of study-treatment-specific safety of BG00010
Change in pain as measured by Likert numerical pain rating scale
Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01405833
Brief Title
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
Official Title
Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).
Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG00010 (Neublastin)
Arm Type
Experimental
Arm Description
Participants may be randomized to escalating doses of BG00010
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants may be randomised to a matching placebo
Intervention Type
Drug
Intervention Name(s)
BG00010 (Neublastin)
Intervention Description
Multiple doses, weight-based IV administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose IV matched placebo
Primary Outcome Measure Information:
Title
Number of Participants experiencing Adverse Events
Time Frame
Throughout the study period- an expected 15 weeks
Title
Serum drug concentrations of BG00010 as a measure of pharmacokinetics
Time Frame
Throughout the study period- an expected 15 weeks
Secondary Outcome Measure Information:
Title
Presence of anti-BG00010 antibodies in serum
Description
Assessment of study-treatment-specific safety of BG00010
Time Frame
Throughout the study period- an expected 15 weeks
Title
Change in pain as measured by Likert numerical pain rating scale
Time Frame
Every day for 3 consecutive days prior to baseline throughout the study period
Title
Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time Frame
Throughout the study period at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
Must rate their pain at >/=40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.
Key Exclusion Criteria:
History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
Current generalized myalgia
Serum creatinine >1.5 x upper limit of normal (ULN).
History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
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
Leiden
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
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