Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

NCT ID: NCT00961766

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-02-29

Brief Summary

The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.

Conditions

Sciatica

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BG00010 (Neublastin)

Participants may be randomized to escalating doses of BG00010 or matching placebo

Group Type: EXPERIMENTAL

BG00010 (Neublastin)

Intervention Type: DRUG

Single dose, weight-based IV administration

Placebo

Participants may be randomized to escalating doses of BG00010 or matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose IV matched placebo

Interventions

BG00010 (Neublastin)

Single dose, weight-based IV administration

Intervention Type: DRUG

Placebo

Single dose IV matched placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.
• Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.
• 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.

Exclusion Criteria

• History of malignancy or clinically significant (as determined by the Investigator) allergies, 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 signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Adelaide, South Australia, Australia

Countries

Australia

References

Rolan PE, O'Neill G, Versage E, Rana J, Tang Y, Galluppi G, Aycardi E. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica. PLoS One. 2015 May 11;10(5):e0125034. doi: 10.1371/journal.pone.0125034. eCollection 2015.

Reference Type: DERIVED

PMID: 25962165 (View on PubMed)

Other Identifiers

103NS101

Identifier Type: -

Identifier Source: org_study_id