Loading clinical trials...

BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01873404•Biogen

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Locations (25)

Research Site

Phoenix, Arizona, United States

Research Site

Fresno, California, United States

Research Site

Lomita, California, United States

Research Site

Long Beach, California, United States

Research Site

Pasadena, California, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Sarasota, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

Sunrise, Florida, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

September 10, 2015

Enrollment

183

ACTUAL participants

Conditions

Painful Lumbar RadiculopathySciaticaRadiculopathy

Interventions

BG00010

DRUG

Placebo

DRUG

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

View study

RECRUITINGNA

Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy

NCT07307846

Cervical RadiculopathyCervical Radicular Pain+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy

Non-surgical Spinal Decompression Therapy and Outcomes

Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain

Prediction of TEI Success in Sciatica

Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation.