Painful Lumbar Radiculopathy, Radiculopathy, Sciatica
Conditions
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.
Interventions
DRUGBG00010
As specified in the treatment arm
DRUGPlacebo
As specified in the treatment arm
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score | At the end of treatment period (Day 6-10) |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI) | At the end of the treatment period (day 6-10) |
| Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI) | Up to week 5 |
| Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI) | Up to week 5 |
| Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI) | Up to week 5 |
| Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score | At the end of the treatment period (day 6-10) |
| Number of participants experiencing adverse events (AEs) | Up to week 9 |
| Number of participants experiencing serious adverse events (SAEs) | Up to week 9 |
| Change from Baseline in Incidence of neutralizing antibodies in serum | Up to week 9 |
| Maximum observed serum concentration (Cmax) of BG00010 | Up to Day 5 |
Countries
United States
Outcome results
None listed