World Health Organization site
Skip Navigation Links

Main
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: 14 December 2015
Main ID:  EUCTR2010-023023-19-DE
Date of registration: 18/11/2011
Prospective Registration: Yes
Primary sponsor: Novartis Farma S.p.A.
Public title: Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosis
Scientific title: A 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy
Date of first enrolment: 04/01/2012
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023023-19
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Germany Italy
Contacts
Name: Medical Competence Center   
Address:  Roonstr. 25 90429 Nürnberg Germany
Telephone: 00491802232300
Email: infoservice.novartis@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Medical Competence Center   
Address:  Roonstr. 25 90429 Nürnberg Germany
Telephone: 00491802232300
Email: infoservice.novartis@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed. 2. Male or female subjects aged 18-60 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 below the 10th 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 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 an acute relapse of MS. 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, atopic dermatitis, psoriasis or Hashimoto's Disease. 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. Patients with negative test for varicella-zoster virus IgG antibodies at screening. If these patients elect to be vaccinated, they may return to be rescreened at least two month after the vaccination. 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 (systemic) or ACTH within 1 month prior to screening; 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 any time, mitoxantrone in the last 12 month. Patients with any medically unstable condition, as assessed by the primary treating physician at each site. Patients with any of the following cardiovascular conditions or conditions for which significant bradycardia may be poorly tolerated: history of cardiac arrest; ? history of myocardial infarction or with known ischemic heart disease (including angina pectoris);? history of symptomatic bradycardia or recurrent syncope;
? cerebrovascular disease;? congestive heart failure;? severe untreated sleep apnea;?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; patients receiving heart rate lowering drugs, e.g. beta-blockers, calcium channel blockers (e.g. verapamil, diltiazem or ivabradine) or other substances which may decrease heart rate (e.g. digoxin, anticholinesteratic agents or pilocarpine); resting pulse rate <45 bpm prior to baseline;?proven history of sick sinus syndrome or sino-atrial heart block; hypertension, not controlled by prescribed medications. Patients with any of the following pulmonary conditions:?pulmonary fibrosis;?active tuberculosis. Patients with any of the following hepatic conditions:?chronic liver or biliary disease;?total bilirubin greater than 2 times the upper limit of the normal range, unless in context of Gilbert’s syndrome; conjugated bilirubin greater than 2 times the upper limit of the normal range;?AST, ALT >2 times the upper limit of the normal range; AP >1.5 times the upper limit


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
treating of cognitive symptoms in relapsing-remitting multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Intervention(s)

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
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: Extavia
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
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: Gilenya
Product Name: Fingolimod
Product Code: FTY720
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: Extavia
Product Name: Extavia
Product Code: NVF233
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)
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 - Sorting Test), 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.
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.
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, how the effects of fingolimod and IFN beta 1b on brain atrophy, on cognitive dysfunction progression and on depression in MS are associated. Changes in QoL, by mean of the MSQoL54, upon initiation of treatment with fingolimod 0.5 mg. Changes in fatigue. Impact of cognitive symptoms on patient work, financial status, assistance required, social activity. Evaluation in a subgroup how the SSTT correlates with results of the BRB or D-KEFS.
Timepoint(s) of evaluation of this end point: 18 months
Secondary Outcome(s)
Secondary end point(s): 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. Evaluation in a subgroup of patients / sites how the Symbol Symbol Transcode Test (SSTT) correlates with results of the BRB or D-KEFS.
Timepoint(s) of evaluation of this end point: 18 months
Secondary ID(s)
2010-023023-19-IT
CFTY720DIT01
Source(s) of Monetary Support
Novartis Farma
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history