NCT00961766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

2.5 years

First QC Date

August 17, 2009

Last Update Submit

October 24, 2014

Conditions

Sciatica

Outcome Measures

Primary Outcomes (9)

  • Number of participants experiencing Adverse Events (AEs)

    Up to 56 days post dosing

  • Change in Likert numerical pain rating scale

    Up to 56 days post dosing

  • Change in Quantitative Sensory Test (QST)

    QST; Vibratory, Cool Thermal,

    Up to 28 days post dosing

  • Change in Intra Epidermal Nerve Fiber Density (IENFD)

    Up to 28 days post dosing

  • Maximum observed serum concentration (Cmax)

    Up to 5 days post dosing

  • Area under the serum concentration curve (AUC)

    Up to 5 days post dosing

  • Terminal half-life (t1/2)

    Up to 5 days post dosing

  • Total body clearance (CL)

    Up to 5 days post dosing

  • Steady state volume of distribution (Vss)

    Up to 5 days post dosing

Study Arms (2)

BG00010 (Neublastin)

EXPERIMENTAL

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

Drug: BG00010 (Neublastin)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BG00010 (Neublastin)DRUG

Single dose, weight-based IV administration

BG00010 (Neublastin)
PlaceboDRUG

Single dose IV matched placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • 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.

    PMID: 25962165DERIVED

MeSH Terms

Conditions

Sciatica

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 19, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

AU(1)