BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy (SPRINT)

Biogen

Status and phase: Completed; Phase 2

Conditions: Painful Lumbar Radiculopathy; Radiculopathy; Sciatica

Treatments: Drug: Placebo; Drug: BG00010

Study type: Interventional

Funder types: Industry

Identifiers

NCT01873404

103NS201

Details and patient eligibility

About

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.

Full description

During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 2 patient groups, including a placebo group

BG00010

Experimental group

Description:

Administered as an IV injection at various dose levels 3 times per week for 1 week

Treatment:

Drug: BG00010

Placebo

Placebo Comparator group

Description:

Matched placebo IV injection 3 times per week for 1 week

Treatment:

Drug: Placebo