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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: 30 June 2014
Main ID:  EUCTR2012-005507-40-IT
Date of registration: 25/02/2013
Prospective Registration: Yes
Primary sponsor: NOVARTIS FARMA S.p.A
Public title: Study to provide access to fingolimod to Multiple Sclerosis patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug
Scientific title: An open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug
Date of first enrolment: 15/04/2013
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005507-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no 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: 1  
Phase: 
Countries of recruitment
Italy
Contacts
Name: DRUG REGULATORY AFFAIRS   
Address:  Largo Umberto Boccioni, 1 21040 ORIGGIO Italy
Telephone: 0390296541
Email: info.studiclinici@novartis.com
Affiliation:  NOVARTIS FARMA
Name: DRUG REGULATORY AFFAIRS   
Address:  Largo Umberto Boccioni, 1 21040 ORIGGIO Italy
Telephone: 0390296541
Email: info.studiclinici@novartis.com
Affiliation:  NOVARTIS FARMA
Key inclusion & exclusion criteria
Inclusion criteria:
Patients eligible for inclusion in this program have to meet all of the following criteria:
- written informed consent must be obtained before any assessment is performed
- patients who completed a global or local fingolimod phase IIIb study in multiple sclerosis
- patients who benefited from fingolimod or do not have suitable approved alternative treatment options, and do not have access to the reimbursed drug.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
Patients meeting any of the following criteria are not eligible for inclusion in the study:
- patients who have access to the reimbursed drug
- premature permanent discontinuation from any fingolimod study due to:
o an adverse event or serious adverse event or laboratory abnormality, except pregnancy
o conditions leading to permanent study drug discontinuation
- any new conditions which would have impeded the enrolment in the previous phase IIIb study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Gilenya
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FINGOLIMOD
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)
Main Objective: - to provide access to fingolimod to patients who completed local or global fingolimod phase IIIb studies in MS who benefited from treatment with fingolimod or do not have suitable alternative treatment options but do not have access to the reimbursed drug.
Primary end point(s): to provide access to fingolimod to patients who completed local or global fingolimod phase IIIb studies in MS who benefited from treatment with fingolimod or do not have suitable alternative treatment options but do not have access to the reimbursed drug.
Secondary Objective: - to generate long-term safety and tolerability data in a population different from that of the EMA approved label and routine medical care.
Timepoint(s) of evaluation of this end point: N.A.
Secondary Outcome(s)
Secondary end point(s): to generate long-term safety and tolerability data in a population different from that of the EMA approved label and routine medical care.
Timepoint(s) of evaluation of this end point: N.A.
Secondary ID(s)
CFTY720DIT07
Source(s) of Monetary Support
NOVARTIS FARMA
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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