relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399
Conditions
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female subjects aged 18-55 years. 3. Patients with relapsing-remitting forms of MS (RRMS) defined by 2005 revised McDonald criteria (McDonald et al 2001; Polman et al 2005). 4. Patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain MRI scan performed in the last six months. 5. Patients with cognitive impairment at screening, defined as at least one test of the Rao’s Brief Repeatable Battery (BRB) with scores falling outside the 90th percentile of the normative data (age- and gender-based). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who had already been treated with multiweekly interferon and had an unsatisfactory response according to the judgment of the investigator. Patients with hyperactive forms of the MS disease according to the judgment of the investigator. Patients with an EDSS>5. Patients with a prior or current diagnosis of Major Depression according to DSM-IV. Patients with a history of chronic disease of the immune system other than MS. History of malignancy of any organ system, within the past 5 years. Patients with uncontrolled diabetes mellitus (HbA1c >7%). Diagnosis of macular edema during Screening Phase. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. Negative for varicella-zoster virus IgG antibodies at Screening. Have received any live or live attenuated vaccines within 2 months prior to baseline. Patients who have received total lymphoid irradiation or bone marrow transplantation. Patients who have been treated with:?corticosteroids or ACTH within 1 month prior to randomization; immunosuppressive medications such as azathioprine or methotrexate within 3 months prior to baseline;?immunoglobulins and/or monoclonal antibodies within 3 months prior to baseline;?cladribine, cyclophosphamide or mitoxantrone at any time. Patients with any medically unstable condition, as assessed by the primary treating physician at each site. Patients with any of the following cardiovascular conditions and/or findings: history of cardiac arrest; myocardial infarction within the past 6 months prior to enrollment or with current unstable ischemic heart disease;?known history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon; cardiac failure at time of Screening (Class III) or any severe cardiac disease as determined by the investigator; history or presence of a Mobitz 2 second degree AV block or a third degree AV block or an increased QTc interval >450 ms in males and >470 ms in females corrected using Bazett’s formula; patients receiving Class Ia and III antitiarrhythmic drugs; resting pulse rate 2 times the upper limit of the normal range; AP >1.5 times the upper limit of the normal range; GGT >3 times the upper limit of the normal range. Patients with any of the abnormal laboratory values: serum creatinine >1.7 mg/dL (150 µmol/L);?WBC count <3,500/mm3 or lymphocyte count <800/mm3. Patients with any of the following disorders:?history of substance abuse in the past 5 years or serious psychiatric condition that may interfere with the subject’s ability to cooperate and comply with the study procedures; progressive neurological disorder, other than MS, which may affect participation in the study. Participation in any clinical research study within 6 months prior to baseline. Pregnant or nursing women, where pregnancy is defined as the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.;Secondary Objective: To evaluate: how the effects on cognitive dysfunction progression are associated to the effect of slowing the brain volume reduction at MRI that DMDs might have in RRMS patients, in the brain as a whole and in specific brain regions. In a subgroup of patients/sites, if and to what extent optical nerve atrophy as assessed by the RNFL thickness at the Spectralis OCT is predictive of the atrophy of the relevant brain regions and of cognitive deterioration and to what extent this is affected by DMD treatment. If fingolimod has effects on depression in MS and how the effects of fingolimod and interferon beta 1b on brain atrophy, on cognitive dysfunction progression and on depression in MS are associated. Changes in quality of life, by mean of the MSQoL54 scale, upon initiation of treatment with fingolimod 0.5 mg. Changes in fatigue. Impact of cognitive symptoms on patient work and financial status, assistance required and social activity, by means of ESS.;Primary end point(s): The primary objective of the study is to evaluate the reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment and to evaluate which test is most sensitive in detecting differences between treatment groups. | — |
Countries
Germany, Italy
Outcome results
None listed