Last updated: 11/03/2018 13:57:49
NOGO-A in Multiple Sclerosis FTIHN/A
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
The preliminary safety and tolerability of single doses of GSK1223249
Timeframe: screening, baseline (pre-dose) and up to 84 days post dose
Secondary outcomes:
Single dose pharmacokinetics.
Timeframe: screening, baseline (pre-dose) and up to 84 days post dose
Interventions:
Enrollment:
3
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Sclerosis
Product
ozanezumab
Collaborators
Not applicable
Study date(s)
February 2010 to August 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion criteria
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.
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.
Trial location(s)
Location
GSK Investigational Site
Heidelberg, Victoria, Australia, VIC 3084
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 112988 can be found on the GSK Clinical Study Register.
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