FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005507-40-IT
Enrollment
Unknown
Registered
2013-02-25
Start date
2013-04-15
Completion date
Unknown
Last updated
2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

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 HYDR

Sponsors

NOVARTIS FARMA S.p.A
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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. ;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.;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.;Timepoint(s) of evaluation of this end point: N.A.—

Secondary

MeasureTime frame
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.—

Countries

Italy

Contacts

Public ContactDRUG REGULATORY AFFAIRS

NOVARTIS FARMA

info.studiclinici@novartis.com0390296541

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026