Clinical trial NCT01873404: BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Lumbar Radiculopathy
Sciatica
Radiculopathy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
timeFrame: At the end of treatment period (Day 6-10)
Secondary outcomes:
measure: Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score
timeFrame: At the end of the treatment period (day 6-10)
measure: Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)
timeFrame: At the end of the treatment period (day 6-10)
measure: Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)
timeFrame: Up to week 5
measure: Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)
timeFrame: Up to week 5
measure: Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)
timeFrame: Up to week 5
measure: Maximum observed serum concentration (Cmax) of BG00010
timeFrame: Up to Day 5
measure: Number of participants experiencing adverse events (AEs)
timeFrame: Up to week 9
measure: Number of participants experiencing serious adverse events (SAEs)
timeFrame: Up to week 9
measure: Change from Baseline in Incidence of neutralizing antibodies in serum
timeFrame: Up to week 9
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Fresno
country: United States
facility: Research Site
state: California
city: Lomita
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Ft. Lauderdale
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Bloomington
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: