NOGO-A in Multiple Sclerosis FTIH

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424423
First received: June 9, 2011
Last updated: May 10, 2012
Last verified: September 2011
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis
Drug: Placebo
Drug: GSK1223249
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Patients With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The preliminary safety and tolerability of single doses of GSK1223249 [ Time Frame: screening, baseline (pre-dose) and up to 84 days post dose ] [ Designated as safety issue: Yes ]
    changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses


Secondary Outcome Measures:
  • Single dose pharmacokinetics. [ Time Frame: screening, baseline (pre-dose) and up to 84 days post dose ] [ Designated as safety issue: No ]
    (AUC(0-∞)


Enrollment: 3
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: GSK1223249
I.V. Infusion
Placebo Comparator: Placebo Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

This is a phase I study of GSK1223249. The study design is randomized, placebo-controlled, double-blind, sequential dose escalation, single dose administration. Approximately 36 patients with relapsing forms of Multiple Sclerosis (having had at least two relapses over the previous 24 months, OR at least one relapse within the last 12 months, OR having had at least one documented gadolinium-enhancing lesion on brain magnetic resonance imaging (MRI) within 12 months prior to Screening) will be enrolled.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424423

Locations
Australia, Victoria
GSK Investigational Site
Heidelberg, Victoria, Australia, VIC 3084
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424423     History of Changes
Other Study ID Numbers: 112988
Study First Received: June 9, 2011
Last Updated: May 10, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by GlaxoSmithKline:
Safety
GSK1223249
Pharmacokinetics
Single dose escalation
anti-GSK1223249 antibodies
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014