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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

July 21, 2011
September 5, 2014
July 2011
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 Pharmacokinetics [ Time Frame: Participants will be followed for the duration of the study; an expected 15 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01405833 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sciatica
  • Drug: BG00010 (Neublastin)
    Multiple doses, weight-based IV administration
  • Drug: Placebo
    Single dose IV matched placebo
  • Experimental: BG00010 (Neublastin)
    Participants may be randomized to escalating doses of BG00010
    Intervention: Drug: BG00010 (Neublastin)
  • Placebo Comparator: Placebo
    Participants may be randomised to a matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
September 2012
September 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01405833
103NS102
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP