Status:
TERMINATED
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 hear...
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 evalua...
Eligibility Criteria
Inclusion
- Diagnosed with a relapsing form of MS .
- Using one of the following ongoing MS treatment strategies, defined as
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01435993
Start Date
September 8 2011
End Date
January 23 2012
Last Update
November 24 2020
Active Locations (2)
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1
GSK Investigational Site
Verona, Veneto, Italy, 37134
2
GSK Investigational Site
Lørenskog, Norway, 1478