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

Sciatica Clinical Trial

Official title:

Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961766
• Other study ID #: 103NS101
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2009
• Last updated: October 24, 2014
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: October 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Key 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.

Key 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.

• History of severe allergic or anaphylactic drug-related reactions. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sciatica

Intervention

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

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing Adverse Events (AEs)		Up to 56 days post dosing	Yes
Primary	Change in Likert numerical pain rating scale		Up to 56 days post dosing	No
Primary	Change in Quantitative Sensory Test (QST)	QST; Vibratory, Cool Thermal,	Up to 28 days post dosing	No
Primary	Change in Intra Epidermal Nerve Fiber Density (IENFD)		Up to 28 days post dosing	No
Primary	Maximum observed serum concentration (Cmax)		Up to 5 days post dosing	No
Primary	Area under the serum concentration curve (AUC)		Up to 5 days post dosing	No
Primary	Terminal half-life (t1/2)		Up to 5 days post dosing	No
Primary	Total body clearance (CL)		Up to 5 days post dosing	No
Primary	Steady state volume of distribution (Vss)		Up to 5 days post dosing	No