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Trial record 1 of 1 for:    01435993
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Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435993
Recruitment Status : Terminated
First Posted : September 19, 2011
Last Update Posted : November 24, 2020
Information provided by (Responsible Party):

Brief Summary:
This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). The study will also investigate if patients' own immune system interacts with GSK1223249.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: GSK1223249 Other: Saline placebo Phase 1

Detailed Description:
This study will be a randomised, placebo-controlled, single-blind (Investigator and Subject), single and repeat ascending dose protocol, in multiple sclerosis patients. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and any potential for immunogenicity of GSK1223249 (a monoclonal antibody raised against Nogo-A), given intravenously in Multiple Sclerosis patients. The study will also evaluate exploratory endpoints including para-clinical activity via magnetic resonance imaging, cerebrospinal fluid pharmacokinetics, and effect of repeat dose administration of GSK1223249 on disability. Furthermore MS symptoms, such as relapses and individual symptom severity will be closely monitored.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.
Actual Study Start Date : September 8, 2011
Actual Primary Completion Date : January 23, 2012
Actual Study Completion Date : January 23, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active
GSK1223249 slow (60 minutes) intravenous infusion
Drug: GSK1223249
Intravenous infusion

Placebo Comparator: Placebo
Saline slow (60 minutes) intravenous infusion
Other: Saline placebo
placebo intravenous infusion

Primary Outcome Measures :
  1. Safety [ Time Frame: every 2-4 weeks over 7 months ]
    • Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)

Secondary Outcome Measures :
  1. Cmax values and AUC(0-∞) [ Time Frame: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up ]
    Profile of Pharamcokinetics

  2. Immunogenicity of GSK1223249 in MS patients [ Time Frame: Predose; Day 85; Day169; Day197 ]
    • Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays.

  3. Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients [ Time Frame: Day7; or Day 29; or Day 35; or Day 85 ]
    Measurement of GSK1223249 in CSF

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with a relapsing form of MS .
  • Using one of the following ongoing MS treatment strategies, defined as

    1. Currently receiving Beta-interferon/Copaxone for treatment of MS and have been receiving the current course of therapy for 3 or more months prior to screening, OR
    2. Not currently receiving disease modifying therapies for treatment of MS, and has not received such therapies for at least 3 months prior to screening.
  • Demonstrated clinical activity in 2 years prior to screening, whilst receiving current/previous treatment regimen or prior to any treatment regimen
  • Expanded Disability Status Scale (EDSS) score ≤6.0 at either the screening or baseline visit.
  • Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
  • Body weight equal to or greater than: 50 kilogrammes

Exclusion Criteria:

  • Complications/History of other diseases that may impact on safety of patients enroling into the study.
  • Liver function test outside normal range for patient population
  • Treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of screening
  • Treatment in the past 6 months with any of the following agents: Fingolimod (Gilenya), methotrexate, mitoxantrone, azathioprine, or other small molecule immunosuppressants.
  • History of anaphilaxis to protein based therapeutics or mono-clonal antibodies.
  • Positive result for Hapatitis B, HIV, and/or drugs of abuse, or excessive alcohol consumption.
  • Not able to undergo MRI scanning safely, or Gadolinium (contrast enhancing agents) during MRI.
  • Other significant infections e.g. Tuberculosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01435993

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GSK Investigational Site
Verona, Veneto, Italy, 37134
GSK Investigational Site
Lørenskog, Norway, 1478
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT01435993    
Other Study ID Numbers: 114840
2010-022664-12 ( EudraCT Number )
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Keywords provided by GlaxoSmithKline:
Multiple Sclerosis, Secondary-Progressive with relapses
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases