Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:12/8/2018
Start Date:September 13, 2010
End Date:October 19, 2018

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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

The purpose of this study is to collect long-term safety and tolerability, long-term
efficacy, and health outcome data in all patients currently ongoing in the fingolimod
multiple sclerosis clinical development program. This study will combine all currently
ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned
studies into one single long-term extension protocol that will provide patients with
continuous treatment and will continue until fingolimod is registered, commercially
available, and reimbursed in the respective countries.


Inclusion Criteria:

- Patients who have completed selected ongoing or planned trials with FTY720.

Exclusion Criteria:

- Premature permanent discontinuation of a previous fingolimod study.

- Pregnant or nursing (lactating) women.

- Women of child-bearing potential, UNLESS they are using two birth control methods, at
least 1 of which must be hormonal contraception, tubal sterilization, partner's
vasectomy or intrauterine device.

- Chronic disease of the immune system, other than multiple sclerosis, which may require
immunosuppressive treatment.

- Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or
proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.

- Active systemic bacterial, viral or fungal infections, or known to have AIDS,
Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface
antigen or Hepatitis C antibody tests.

- Previous treatment with cladribine, cyclophosphamide or mitoxantrone.

- Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in
the past 3 months during the previous fingolimod study:

- Any of the following cardiovascular conditions that have developed during the previous
fingolimod study:

- Myocardial infarction within the past 6 months prior to entry in the extension
study or with current unstable ischemic heart disease;

- Cardiac failure (Class III, according to New York Heart Association
Classification) or any severe cardiac disease as determined by the investigator;

- Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g.,
amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)

- History or presence of a third degree AV block

- Proven history of sick sinus syndrome or sino-atrial heart block

- Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon

- Any of the following pulmonary conditions during the previous fingolimod study:

- Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous
fingolimod study)

- Active tuberculosis

- Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to
participate in this trial.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
35
sites
Pittsburgh, Pennsylvania 15224
974
mi
from
Pittsburgh, PA
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Albuquerque, New Mexico 87108
520
mi
from
Albuquerque, NM
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Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
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Baltimore, Maryland 21287
1149
mi
from
Baltimore, MD
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Baltimore, Maryland 21287
1149
mi
from
Baltimore, MD
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Bristol, Tennessee 37620
863
mi
from
Bristol, TN
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Burlington, Vermont 05401
1356
mi
from
Burlington, VT
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Caba, Buenos Aires
5602
mi
from
Caba,
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Charlottesville, Virginia 22904
1051
mi
from
Charlottesville, VA
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Cullman, Alabama 35058
661
mi
from
Cullman, AL
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Durham, North Carolina 27710
1048
mi
from
Durham, NC
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Jacksonville, Florida 32216
1061
mi
from
Jacksonville, FL
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Kansas City, Kansas 66160
195
mi
from
Kansas City, KS
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Kansas City, Missouri 64111
196
mi
from
Kansas City, MO
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Lebanon, New Hampshire 03756
1393
mi
from
Lebanon, NH
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Lenexa, Kansas 66212
189
mi
from
Lenexa, KS
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Maitland, Florida 32751
1138
mi
from
Maitland, FL
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Miami, Florida 33136
1320
mi
from
Miami, FL
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Nashville, Tennessee 37205
615
mi
from
Nashville, TN
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1290
mi
from
New York, NY
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Oceanside, California 92056
1138
mi
from
Oceanside, CA
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Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Pompano Beach, Florida 33060
1303
mi
from
Pompano Beach, FL
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Raleigh, North Carolina 27609
1068
mi
from
Raleigh, NC
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Sacramento, California 95825
1278
mi
from
Sacramento, CA
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
576
mi
from
San Antonio, TX
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San Francisco, California 94121
1343
mi
from
San Francisco, CA
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Seattle, Washington 98103
1412
mi
from
Seattle, WA
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Tallahassee, Florida 32308
924
mi
from
Tallahassee, FL
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Tampa, Florida 33613
1111
mi
from
Tampa, FL
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Toledo, Ohio 43606
800
mi
from
Toledo, OH
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Tualatin, Oregon 97062
1385
mi
from
Tualatin, OR
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Tulsa, Oklahoma 74104
151
mi
from
Tulsa, OK
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Vero Beach, Florida 32960
1227
mi
from
Vero Beach, FL
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Washington, District of Columbia 20007
1127
mi
from
Washington,
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