Back to resultsEvaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Primary Purpose
Sciatica
Status
Completed
Phase
Phase 1
Locations
Australia
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. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.
- Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.
- 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 significant (as determined by the Investigator) allergies, 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 signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.
- History of severe allergic or anaphylactic drug-related reactions. 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 or matching placebo
Participants may be randomized to escalating doses of BG00010 or matching placebo
Outcomes
Primary Outcome Measures
Number of participants experiencing Adverse Events (AEs)
Change in Likert numerical pain rating scale
Change in Quantitative Sensory Test (QST)
QST; Vibratory, Cool Thermal,
Change in Intra Epidermal Nerve Fiber Density (IENFD)
Maximum observed serum concentration (Cmax)
Area under the serum concentration curve (AUC)
Terminal half-life (t1/2)
Total body clearance (CL)
Steady state volume of distribution (Vss)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00961766
Brief Title
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Official Title
Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 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 determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.
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
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG00010 (Neublastin)
Arm Type
Experimental
Arm Description
Participants may be randomized to escalating doses of BG00010 or matching placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants may be randomized to escalating doses of BG00010 or matching placebo
Intervention Type
Drug
Intervention Name(s)
BG00010 (Neublastin)
Intervention Description
Single dose, 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 (AEs)
Time Frame
Up to 56 days post dosing
Title
Change in Likert numerical pain rating scale
Time Frame
Up to 56 days post dosing
Title
Change in Quantitative Sensory Test (QST)
Description
QST; Vibratory, Cool Thermal,
Time Frame
Up to 28 days post dosing
Title
Change in Intra Epidermal Nerve Fiber Density (IENFD)
Time Frame
Up to 28 days post dosing
Title
Maximum observed serum concentration (Cmax)
Time Frame
Up to 5 days post dosing
Title
Area under the serum concentration curve (AUC)
Time Frame
Up to 5 days post dosing
Title
Terminal half-life (t1/2)
Time Frame
Up to 5 days post dosing
Title
Total body clearance (CL)
Time Frame
Up to 5 days post dosing
Title
Steady state volume of distribution (Vss)
Time Frame
Up to 5 days post dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.
Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.
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 significant (as determined by the Investigator) allergies, 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 signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.
History of severe allergic or anaphylactic drug-related reactions. 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
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25962165
Citation
Rolan PE, O'Neill G, Versage E, Rana J, Tang Y, Galluppi G, Aycardi E. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica. PLoS One. 2015 May 11;10(5):e0125034. doi: 10.1371/journal.pone.0125034. eCollection 2015.
Results Reference
derived
Learn more about this trial
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
We'll reach out to this number within 24 hrs