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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00961766




Registration number
NCT00961766
Ethics application status
Date submitted
17/08/2009
Date registered
19/08/2009
Date last updated
28/10/2014

Titles & IDs
Public title
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Scientific 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
Secondary ID [1] 0 0
103NS101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sciatica 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BG00010 (Neublastin)
Treatment: Drugs - Placebo

Experimental: BG00010 (Neublastin) - Participants may be randomized to escalating doses of BG00010 or matching placebo

Placebo Comparator: Placebo - Participants may be randomized to escalating doses of BG00010 or matching placebo


Treatment: Drugs: BG00010 (Neublastin)
Single dose, weight-based IV administration

Treatment: Drugs: Placebo
Single dose IV matched placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to 56 days post dosing
Primary outcome [2] 0 0
Change in Likert numerical pain rating scale
Timepoint [2] 0 0
Up to 56 days post dosing
Primary outcome [3] 0 0
Change in Quantitative Sensory Test (QST)
Timepoint [3] 0 0
Up to 28 days post dosing
Primary outcome [4] 0 0
Change in Intra Epidermal Nerve Fiber Density (IENFD)
Timepoint [4] 0 0
Up to 28 days post dosing
Primary outcome [5] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [5] 0 0
Up to 5 days post dosing
Primary outcome [6] 0 0
Area under the serum concentration curve (AUC)
Timepoint [6] 0 0
Up to 5 days post dosing
Primary outcome [7] 0 0
Terminal half-life (t1/2)
Timepoint [7] 0 0
Up to 5 days post dosing
Primary outcome [8] 0 0
Total body clearance (CL)
Timepoint [8] 0 0
Up to 5 days post dosing
Primary outcome [9] 0 0
Steady state volume of distribution (Vss)
Timepoint [9] 0 0
Up to 5 days post dosing

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00961766
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00961766