Multiple Sclerosis Depression MedDRA version: 14.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Gilenya
Product Name: Gilenya
Pharmaceutical Form: Capsule, hard
CAS Number: 162359-56-0
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed. 2. Male or female subjects aged 18-65 years. 3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4). 4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix 8). 5. Patients with high disease activity despite treatment with a disease modifying therapy (> 1 relapse in the previous year, > 9 hyperintense T2 lesions or > 1 Gd-enhancing lesion or “non-responding” which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year) or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI). or patients who are already treated with fingolimod within the EU label criteria for at least 7 days with or without having participated and completed study CFTY720DDE17 6. Diagnosis of depression according to ICD-10 criteria 7. Mild-moderate depression assessed by BDI-II score between 14-28 inclusively measured on V1 and on V2 8. Sufficient ability to read, write, communicate and understand 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 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a history of chronic disease of the immune system other than MS which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. Patients with Crohns disease or ulcerative colitis are excluded without exception. 2. History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin). 3. 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. 4. Negative for varicella-zoster virus IgG antibodies at Screening. 5. Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to start of fingolimod. 6. Patients who have received total lymphoid irradiation or bone marrow transplantation. 7. Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-ß, glatiramer acetate); however no washout is needed for DMDs prior to start of fingolimod. 8. Patients who are or have been treated with: • immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to start of fingolimod • Systemically applied corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to Screening visit (V1) (nevertheless, topical application is permitted); • Immunosuppressive medications such as azathioprine or methotrexate, within 3 months prior to start of fingolimod; • Cyclophosphamid and mitoxantrone within 6 months prior to start of fingolimod • cladribine at any time. • current psychological or pharmacological treatment for depression (MAO inhibitors in particular), a washout period of 14 days prior visit 2 is required • current treatment with linezolid, a washout period of 1 month prior start of fingolimod is required 9. Patients with any medically unstable condition, as assessed by the primary treating physician at each site. 10. Patients with any of the following cardiovascular conditions: ? Patients receiving antiarrythmics class Ia (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol) or beta blockers ? Patients receiving heart rate lowering calcium channel blockers (e.g. verapamil, diltiazem or ivabradine) or other substances which may decrease heart rate (e.g. digoxin, anticholinesteratic agents or pilocarpine). ? 2nd degree Mobitz Type II or higher degree AV block, Sick-sinus syndrome, or Sino-atrial heart block ? Significant QT prolongation (QTc>470 msec (female) or >450 msec (males)) ? History of symptomatic bradycardia or recurrent syncope, known ischaemic heart disease, cerebrovascular disease, history of myocardial infarction, hypokalaemia, congestive heart failure, history of cardiac arrest, uncontrolled hypertension, or severe sleep apnea ? resting 11. Patients with severe hepatic dysfunction (Child-Pugh-Class C) 12. Patients who are not currently treated with fingolimod with the following cell counts: white blood cell (WBC) count <3,500/mm3 or lymphocyte count <800/mm3. Patients who are currently treated with fingolomod with the following cell counts: white blood cell (WBC) count <3,500/mm3 or lymphocyte count <200/mm3 13. Patients with any of the following neurologic/psychiatric disorders: • history of substance abuse (drug or alcohol) in the past five years or any other factor (i.e. serious psychiatric condition) t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability profile of the combination therapy of an antidepressant type SSRI or SNRI with oral fingolimod with respect to adverse events and laboratory parameters;Secondary Objective: Not applicable;Primary end point(s): safety and tolerability profile of the combination therapy of an antidepressant type SSRI or SNRI with oral fingolimod with respect to adverse events and laboratory parameters;Timepoint(s) of evaluation of this end point: 21 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany
Contacts
Public ContactProject Leader
Novartis Pharma GmbH
Outcome results
None listed