Last updated: 11/21/2020 12:10:37
Multiple doses of Anti-NOGO A in relapsing forms of Multiple Sclerosis
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Safety
Timeframe: every 2-4 weeks over 7 months
Secondary outcomes:
Cmax values and AUC(0-∞)
Timeframe: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up
Immunogenicity of GSK1223249 in MS patients
Timeframe: Predose; Day 85; Day169; Day197
Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients
Timeframe: Day7; or Day 29; or Day 35; or Day 85
Interventions:
Drug: GSK1223249
Other: Saline placebo
Enrollment:
3
Observational study model:
Not applicable
Primary completion date:
2012-23-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Sclerosis, Relapsing-Remitting
Product
ozanezumab
Collaborators
Not applicable
Study date(s)
September 2011 to January 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
No
- Diagnosed with a relapsing form of MS .
- Using one of the following ongoing MS treatment strategies, defined as
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosed with a relapsing form of MS .
- Using one of the following ongoing MS treatment strategies, defined as a.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 b.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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
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
Terminated (halted prematurely)
Actual primary completion date
2012-23-01
Actual study completion date
2012-23-01
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
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website