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

Sciatica Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405833
• Other study ID #: 103NS102
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2011
• Last updated: September 5, 2014
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• BG00010 (Neublastin)
Multiple doses, weight-based IV administration
• Placebo
Single dose IV matched placebo

Locations

Country	Name	City	State
Netherlands	Research Site	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants experiencing Adverse Events		Throughout the study period- an expected 15 weeks	Yes
Primary	Serum drug concentrations of BG00010 as a measure of pharmacokinetics		Throughout the study period- an expected 15 weeks	No
Secondary	Presence of anti-BG00010 antibodies in serum	Assessment of study-treatment-specific safety of BG00010	Throughout the study period- an expected 15 weeks	Yes
Secondary	Change in pain as measured by Likert numerical pain rating scale		Every day for 3 consecutive days prior to baseline throughout the study period	No
Secondary	Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)		Throughout the study period at each visit	No