Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00961766