EUCTR2010-020515-37-DE
Active, not recruiting
Phase 1
A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- multiple sclerosis
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 4125
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1\. Written informed consent must be obtained before any assessment is performed.
- •2\. Patients who have completed designated ongoing or planned Novartis global clinical trials with fingolimod and are unable to obtain fingolimod outside a clinical trial.
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •1\. Premature permanent discontinuation from any fingolimod study due to:
- •a. An adverse event or serious adverse event or laboratory abnormality, except pregnancy.
- •b. Conditions leading to permanent study drug discontinuation.
- •Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy can be re\-enrolled.
- •2\. Pregnant or nursing (lactating) women, where pregnancy is defined
- •as the state of a female after conception and until the termination of
- •gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/ml).
- •Patients who temporarily or permanently discontinued from any
- •fingolimod study because of pregnancy can be re\-enrolled.
Outcomes
Primary Outcomes
Not specified
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