Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Side effects. Special attention for bradyarrythmia (AV conduction
disturbances), ophthalmic and skin abnormalities.
Secondary outcome
incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices
for Multiple Sclerosis (PRIMuS) en Short Form Health Survey*12 (SF-12),
Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Background summary
Fingolimod (FTY720) is a new oral treatment for multiple sclerosis (MS). The
application for a market authorization has been submitted to the authorities.
It is an immunosupperssant. Fingolimod decreases the number of activated
T-cells in blood and in the CNS by binding to the sphingosin-1-phosphate
receptor-1 (S1P1) on circulating lymfocytes. This binding results in a
reversible sequestration of T-cells, thus *trapping* autoagressive T-cells in
peripheral lymoid tissues. Therefore they are not able to migrate to areas of
inflammation in the CNS.
Fingolimod reduces the number of MS relapses and improves the MRI findings and
inflammatory markers.
The current study has been designed to further explore safety and tolerability
of fingolimod in a broader population of MS patients compared to previous phase
III studies.
Study objective
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population
of MS patients.
Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported
Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*
12 (SF-12), Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Study design
Open, non-comparative phase IIIB safety study with fingolimod 0,5 mg daily
during 4 months. 1st dose of study medication will be given in the clinic or at
home, depending on the findings of the screening 24 h Holter monitoring. Hotler
monitoring during at least 6 h post intake of the 1st dose.
Approx. 2400 patients.
Patiënten may be eligible for a follow-up study after completion of this study.
Intervention
Treatment with fingolimod.
Study burden and risks
Risks: Adverse effects of study medication.
Burden: 5-6 visits in 30 weeks. During all visits vital signs, blood tests
(10-15 ml per visits, 75 ml in total; during screening HIV and hepatitis B-C)
and pregnancy test (if relevant). 5x physical examination, 2x ECG, 2x
Holtermonitoring (24 and 6 h), 2x ophthalmalogical examination (incl. OCT
measurement), 1x skin examination. 2x (visits 1 or 2 and 5) completion of
Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short
Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for
Medication (TSQM-9).
Advice for monthly self-inspection of the skin.
Raapopseweg 1
6824 DP Arnhem
NL
Raapopseweg 1
6824 DP Arnhem
NL
Listed location countries
Age
Inclusion criteria
* Male or female subjects aged 18-65 years.
* Subjects with relapsing forms of MS.
* EDSS score 0-6.5.
Exclusion criteria
* Patients with a history of chronic disease of the immune system other than MS.
* Uncontrolled diabetes mellitus (HbA1c > 7%).
* Diagnosis of macular edema during Screening Phase.
* Patients with active systemic bacterial, viral or fungal infections. Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
* Negative for varicella-zoster virus IgG antibodies at Screening.
* Have received any live or live attenuated vaccines within 1 month prior to baseline.
* Corticosteroids or ACTH within 1 month prior to baseline.
* Immunosuppressive medications within 3 months prior to baseline.
* Immunoglobulins and/or monoclonal antibodies within 3 months prior to baseline.
* Cladribine, cyclophosphamide or mitoxantrone at any time.
* Patients with impaired cardiovascular condition and/or findings in the screening ambulatory 24-hour ECG-recording (see protocol for details).
* Pulmonary fibrosis.
* Abnormal liver conditions (see protocol for details).
* Pregnancy, lactation, inadequate contraception.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov; registratienummer nog niet bekend |
| EudraCT | EUCTR2010-019029-32-NL |
| CCMO | NL32141.029.10 |