Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01405833
First received: July 21, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of BG00010 after multiple dose intravenous (IV) administration to sciatica subjects


Condition Intervention Phase
Sciatica
Drug: BG00010
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a measure of safety and tolerability [ Time Frame: Participants will be followed for the duration of the study; an expected 15 weeks ] [ Designated as safety issue: Yes ]
  • Serum Concentrations of BG00010 as a measure of Phamacokinetics [ Time Frame: Participants will be followed for the duration of the study; an expected 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00010 or matching placebo
Subjects may be randomised to escalating doses of BG00010 or matching placebo
Drug: BG00010
Multiple doses, weight-based IV administration
Other Name: Neublastin. All IV except for Cohort K
Drug: Placebo
Single dose IV matched placebo

Detailed Description:

This study expands on 101NS101, which is a single ascending dose (SAD) study. Subjects will receive multiple doses of BG00010 administered in 2 fixed schedules. Doses and schedules for this study were selected based on safety and PK observations from 103NS101, projected efficacious doses and schedule of BG00010 from nonclinical studies and nonclinical toxicology studies.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must give written informed consent and any authorizations required by local law
  • Must be aged 18 to 85 years old, inclusive, at the time of informed consent.
  • Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
  • 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.
  • All male and female subjects of child-bearing potential must practice effective contraception during the study and will be willing and able to continue contraception for 3 months after their last dose of study treatment.

Exclusion Criteria:

  • History of malignancy or clinically relevant allergies and/or 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 severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
  • Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
  • History of severe allergic or anaphylactic drug-related reactions.
  • Major surgery within the 3 months prior to the Screening Visit or planned sciatica surgery within 6 months of the Screening Visit.
  • Current generalized myalgia
  • Fever (body temperature >38oC) or symptomatic viral or bacterial infection within 2 weeks prior to the Baseline Visit.
  • Laboratory value at the Screening or Baseline Visits that is outside the normal range, unless it is judged by the Investigator as not clinically relevant after appropriate evaluation.
  • Serum creatinine >1.5 x upper limit of normal (ULN).
  • History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
  • Clinically relevant abnormal electrocardiogram (ECG, 12-lead) at the Screening or Baseline Visits, as determined by the Investigator. Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at the Screening or Baseline Visits will not be allowed to enroll into the study.
  • Previous participation in a study with neurotrophic factors.
  • Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit.
  • Any immunization/vaccination within 28 days prior to the Baseline Visit.
  • Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit. Selective serotonin reuptake inhibitor (SSRI), serotonin noradrenaline reuptake inhibitor (SNRI), gabapentin, and tricyclic antidepressant (TCA) doses must be stable for 4 weeks prior to the Baseline Visit. Pregabalin dose must be stable for 1 week prior to the Baseline Visit.
  • Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
  • Relevant history of illicit drug or alcohol abuse (as determined by the Investigator) within 1 year of the Screening Visit. Subjects who have a positive urine drug test at the Screening or Baseline Visits may be enrolled at the discretion of the Investigator.
  • Blood donation (1 unit or more) within 1 month prior to the Screening Visit.
  • Smoke >5 cigarettes per day.
  • Current enrollment in any other study.
  • Any alcohol use within 24 hours prior to dosing on Day 1.
  • Vigorous exercise (i.e., greater than 30 minutes of aerobic exercise) within 48 hours prior to dosing on Day 1.
  • Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405833

Locations
Netherlands
Research Site
Leiden, Netherlands
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT01405833     History of Changes
Other Study ID Numbers: 103NS102
Study First Received: July 21, 2011
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014