Status and phase
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Treatments
About
This was a 24-month, open-label, multicenter study with a single treatment arm design.
Primary objective of this study was:
-To investigate the effects of Fingolimod on cognitive performance in highly active relapsing remitting multiple sclerosis patients
Secondary objectives of this study were:
Polulation The hope was to recruit a minimum of 80 relapsing remitting MS (RRMS) patients according to the McDonald criteria.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diagnosed with RRMS as described in 2010 McDonald criteria (36)
Provided written informed consent prior to any intervention
Unresponsive to treatment with a beta interferon or glatiramer acetate for a minimum of one year at and at adequate dose and with high disease activity .
(Unresponsive patients: patients with no changes in relapses, increased relapses, severer relapses with one-year treatment or those who had had at least one relapse during the past one year under previous treatments and one or multiple contrast enhancing lesions in cranial MRI or increased T2 lesions in successive MRIs)
EDSS score below 5.5 at screening
Exclusion criteria
Patients with primary or secondary progressive or progressive relapsing MS. 2. Patients with known contraindications for fingolimod treatment. 3. Other coexistent autoimmune diseases including Hashimoto thyroiditis, systemic lupus erythematosus, rheumatoid anthiritis, psoriasis etc.
Patients with any of the following cardiovascular conditions:
Resting heart rate < 45 bpm/min
Cardiac failure at any time during the first study visit (Class III as per NYHA classification) or significant heart disease as judged by the physician
Myocardial infarction during the last 6 months
History of Mobitz Type II grade 2 AV block
Past or current grade 3 AV block
Confirmed history of sick sinus syndrome or sino-atrial heart block
arrhythmia requiring current treatment with Class Ia drugs (ajmaline, disopyramid, procainamide, quinidine)
hypertension uncontrolled with medication 5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, detected by urinalysis and confirmed by a positive hCG laboratory test.
Negative for varicella-zoster virus IgG antibodies at screening. Patients who have negative results for varicella-zoster virus IgG antibodies can be included in the study after vaccination for varicella-zoster virus.
Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively 9. History of previous fingolimod therapy 10. Patient who received any of the treatments below:
Corticosteroids or adrenocorticotropic hormone (ACTH) during the last 1 month
Immunosuppressive medications such as azathioprine or methotrexate etc.
Immunoglobulin treatment during the last 3 months
Cladribine, cyclophosphamide, mitoxantrone, natalizumab at any time
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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