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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 9 December 2013
Main ID:  EUCTR2011-001692-39-DE
Date of registration: 08/06/2011
Prospective Registration: Yes
Primary sponsor: Novartis Pharma GmbH
Public title: A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depression
Scientific title: A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression
Date of first enrolment:
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001692-39
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Germany
Contacts
Name: Project Leader   
Address:  Roonstr. 25 90429 Nürnberg Germany
Telephone: 004991127313135
Email: katrin.schuh@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Project Leader   
Address:  Roonstr. 25 90429 Nürnberg Germany
Telephone: 004991127313135
Email: katrin.schuh@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

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 type: equal
Concentration number: 0.5-

Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Pharmaceutical Form: Capsule, hard
CAS Number: 99300-78-4
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
Pharmaceutical Form: Tablet
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
CAS Number: 59333-67-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Pharmaceutical Form: Capsule, hard
CAS Number: 99300-78-4
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
Pharmaceutical Form: Tablet
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
CAS Number: 59333-67-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

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 type: equal
Concentration number: 0.5-

Primary Outcome(s)
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
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
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: 21 weeks
Secondary Outcome(s)
Secondary end point(s): Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary ID(s)
CFTY720DDE06
Source(s) of Monetary Support
Novartis Pharma GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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