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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00961766
Ethics application status
Date submitted
17/08/2009
Date registered
18/08/2009
Date last updated
24/10/2014

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) - QST; Vibratory, Cool Thermal,
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications