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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01405833
First received: July 21, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).

Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.


Condition Intervention Phase
Sciatica
Drug: BG00010 (Neublastin)
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 experiencing Adverse Events [ Time Frame: Throughout the study period- an expected 15 weeks ] [ Designated as safety issue: Yes ]
  • Serum drug concentrations of BG00010 as a measure of pharmacokinetics [ Time Frame: Throughout the study period- an expected 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of anti-BG00010 antibodies in serum [ Time Frame: Throughout the study period- an expected 15 weeks ] [ Designated as safety issue: Yes ]
    Assessment of study-treatment-specific safety of BG00010

  • Change in pain as measured by Likert numerical pain rating scale [ Time Frame: Every day for 3 consecutive days prior to baseline throughout the study period ] [ Designated as safety issue: No ]
  • Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Throughout the study period at each visit ] [ 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 (Neublastin)
Participants may be randomized to escalating doses of BG00010
Drug: BG00010 (Neublastin)
Multiple doses, weight-based IV administration
Placebo Comparator: Placebo
Participants may be randomised to a matching placebo
Drug: Placebo
Single dose IV matched placebo

  Eligibility

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

Key Inclusion Criteria:

  • 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.

Key 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.
  • Current generalized myalgia
  • 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).
  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405833

Locations
Netherlands
Research Site
Leiden, Netherlands
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01405833     History of Changes
Other Study ID Numbers: 103NS102
Study First Received: July 21, 2011
Last Updated: September 5, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014