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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01424423




Registration number
NCT01424423
Ethics application status
Date submitted
9/06/2011
Date registered
29/08/2011
Date last updated
20/09/2017

Titles & IDs
Public title
NOGO-A in Multiple Sclerosis FTIH
Scientific title
A Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy
Secondary ID [1] 0 0
112988
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - GSK1223249

Experimental: Subjects receiving GSK1223249 in cohort 1 - Eligible subjects will receive intravenous infusion of GSK1223249 with a starting dose of 0.02 milligrams per kilograms, followed by 0.2, 2, 10 and 30 milligrams per kilograms, administered by a programmable syringe pump.

Placebo comparator: Subjects receiving placebo in cohort 1 - Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Experimental: Subjects receiving GSK1223249 in cohort 2 - Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 0.2 milligrams per kilograms administered by a programmable syringe pump.

Placebo comparator: Subjects receiving placebo in cohort 2 - Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Experimental: Subjects receiving GSK1223249 in cohort 3 - Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 2 milligrams per kilograms administered by a programmable syringe pump.

Placebo comparator: Subjects receiving placebo in cohort 3 - Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Experimental: Subjects receiving GSK1223249 in cohort 4 - Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 10 milligrams per kilograms administered by a programmable syringe pump.

Placebo comparator: Subjects receiving placebo in cohort 4 - Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Experimental: Subjects receiving GSK1223249 in cohort 5 - Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 30 milligrams per kilograms administered by a programmable syringe pump.

Placebo comparator: Subjects receiving placebo in cohort 5 - Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: GSK1223249
I.V. Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The preliminary safety and tolerability of single doses of GSK1223249
Timepoint [1] 0 0
screening, baseline (pre-dose) and up to 84 days post dose
Secondary outcome [1] 0 0
Single dose pharmacokinetics.
Timepoint [1] 0 0
screening, baseline (pre-dose) and up to 84 days post dose

Eligibility
Key inclusion criteria
* Suitable as determined by the Principal Investigator, based on his/her overall evaluation. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Diagnosed with a relapsing form of MS defined as either
* Relapsing Remitting MS according to revised McDonald Criteria [McDonald, 2001; Polman, 2005] plus any one of the following:

Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.

OR

-Secondary Progressive MS, plus any one of the following: Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.

* Expanded Disability Status Scale (EDSS) score =5.5
* Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Abnormal baseline blood tests
* Treatment with interferon-beta-1b (Betaferon), interferon-beta-1a (Rebif or Avonex), or glatiramer acetate (Copaxone) within 90 days of dosing.
* Treatment with methylprednisolone or any other systemic steroids within 60 days of dosing.
* Treatment within the past 12 months or currently with any of the following agents: cyclosporine, azathioprine, methotrexate, cladribine, natalizumab (Tysabri®) or other monoclonal antibodies, murine protein, T-cell vaccination, plasmapheresis, IVI gG, ,stem cell transplantation.
* History of intolerance to acetominophen, ibuprofen, naproxen or any other non-steroidal anti-inflammatory agent which would preclude use of at least one of these during the study.
* Previous history of anaphylaxis, severe allergic reaction, or hypersensitivity to albumin or a protein-based therapeutic, including natalizumab (Tysabri) or any other monoclonal antibody. History of hypersensitivity to any of the components of the formulation.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
* Patients with evidence of dementia or psychiatric illness which, in the Investigator's opinion, is likely to prevent them from a full understanding of and/or compliance with the study requirements and procedures.

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


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2010
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
VIC 3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth.

The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).
Trial website
https://clinicaltrials.gov/study/NCT01424423
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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/NCT01424423