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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
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/study/NCT00961766
Trial related presentations / publications
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.
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/study/NCT00961766