Phase
Condition
Memory Loss
Neurologic Disorders
Scar Tissue
Treatment
Placebo capsule
Interferon beta-1a
Placebo i.m. injection
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria Core Phase:
diagnosis of multiple sclerosis
at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive
Key Exclusion Criteria Core Phase:
patients with progressive MS
patients with an active, chronic disease of the immune system other than MS
patients meeting the definition of ADEM
patients with severe cardiac disease or significant findings on the screening ECG.
patients with severe renal insufficiency
Key Inclusion Criteria Extension Phase:
Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug.
Applies to patients newly recruited to participate in the Extension Phase.
All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria.
Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients.
Key Exclusion Criteria Extension Phase:
Applies to patients who completed the Core Phase, but prematurely discontinued study drug.
- Premature discontinuation of the study drug during the Core Phase due to:
an adverse event,
serious adverse event,
laboratory abnormality
other conditions leading to permanent study drug discontinuation due to safety reasons
- Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required.
Applies to patients newly recruited in the younger cohort to participate in the Extension Phase.
- All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Parkville, Victoria 3052
AustraliaSite Not Available
Novartis Investigative Site
Vienna, 1090
AustriaSite Not Available
Novartis Investigative Site
Wien, 1090
AustriaSite Not Available
Novartis Investigative Site
Grodno, 230029
BelarusSite Not Available
Novartis Investigative Site
Minsk, 220114
BelarusSite Not Available
Novartis Investigative Site
Vitebsk, 210023
BelarusSite Not Available
Novartis Investigative Site
Vitoria, ES 29040-091
BrazilSite Not Available
Novartis Investigative Site
Belo Horizonte, Minas Gerais 30150 221
BrazilSite Not Available
Novartis Investigative Site
Rio de Janeiro, RJ 20270-004
BrazilSite Not Available
Novartis Investigative Site
Santos, SP 11015-470
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 05403-000
BrazilSite Not Available
Novartis Investigative Site
São Paulo, SP 05403-900
BrazilSite Not Available
Novartis Investigative Site
Goiania, 74605 020
BrazilSite Not Available
Novartis Investigative Site
Goiânia, 74605-020
BrazilSite Not Available
Novartis Investigative Site
Sofia, 1113
BulgariaSite Not Available
Novartis Investigative Site
Calgary, Alberta T3B 6A8
CanadaSite Not Available
Novartis Investigative Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Novartis Investigative Site
Osijek, 31000
CroatiaSite Not Available
Novartis Investigative Site
Praha 5, 150 06
Czech RepublicSite Not Available
Novartis Investigative Site
Tallinn, 10617
EstoniaSite Not Available
Novartis Investigative Site
Bordeaux, Aquitaine 33076
FranceSite Not Available
Novartis Investigative Site
Bordeaux Cedex, 33076
FranceSite Not Available
Novartis Investigative Site
Le Kremlin Bicetre, 94275
FranceSite Not Available
Novartis Investigative Site
Marseille, 13885
FranceSite Not Available
Novartis Investigative Site
Marseille Cedex 05, 13885
FranceSite Not Available
Novartis Investigative Site
Montpellier, 34295
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31026
FranceSite Not Available
Novartis Investigative Site
Toulouse Cedex, 31059
FranceSite Not Available
Novartis Investigative Site
Goettingen, Niedersachsen 37075
GermanySite Not Available
Novartis Investigative Site
Aschaffenburg, 63739
GermanySite Not Available
Novartis Investigative Site
Bochum, 44791
GermanySite Not Available
Novartis Investigative Site
Bonn, 53111
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Essen, 45147
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Hamburg, 20246
GermanySite Not Available
Novartis Investigative Site
Koeln, 51109
GermanySite Not Available
Novartis Investigative Site
Muenchen, 80337
GermanySite Not Available
Novartis Investigative Site
Muenster, 48149
GermanySite Not Available
Novartis Investigative Site
Tübingen, 72076
GermanySite Not Available
Novartis Investigative Site
Bari, BA 70124
ItalySite Not Available
Novartis Investigative Site
Montichiari, BS 25018
ItalySite Not Available
Novartis Investigative Site
Catania, CT 95123
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20132
ItalySite Not Available
Novartis Investigative Site
Cefalu, PA 90015
ItalySite Not Available
Novartis Investigative Site
Cefalù, PA 90015
ItalySite Not Available
Novartis Investigative Site
Padova, PD 35128
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00189
ItalySite Not Available
Novartis Investigative Site
Gallarate, VA 21013
ItalySite Not Available
Novartis Investigative Site
Napoli, 80131
ItalySite Not Available
Novartis Investigative Site
Riga, LV-1004
LatviaSite Not Available
Novartis Investigative Site
Kaunas, LTU LT 50161
LithuaniaSite Not Available
Novartis Investigative Site
Vilnius, LT-08406
LithuaniaSite Not Available
Novartis Investigative Site
Ciudad De Mexico, D F 06700
MexicoSite Not Available
Novartis Investigative Site
Mexico, Distrito Federal 03310
MexicoSite Not Available
Novartis Investigative Site
México, Distrito Federal 04530
MexicoSite Not Available
Novartis Investigative Site
Culiacan, Sinaloa 80020
MexicoSite Not Available
Novartis Investigative Site
Merida, Yucatan 97125
MexicoSite Not Available
Novartis Investigative Site
Distrito Federal, 03310
MexicoSite Not Available
Novartis Investigative Site
Mexico City, 3310
MexicoSite Not Available
Novartis Investigative Site
Rotterdam, 3015 CN
NetherlandsSite Not Available
Novartis Investigative Site
Lodz, 93-338
PolandSite Not Available
Novartis Investigative Site
Lublin, 20-093
PolandSite Not Available
Novartis Investigative Site
Poznan, 60-355
PolandSite Not Available
Novartis Investigative Site
Warsaw, 04-730
PolandSite Not Available
Novartis Investigative Site
Wroclaw, 50 420
PolandSite Not Available
Novartis Investigative Site
Santurce, 00912
Puerto RicoCompleted
San Jorge Childrens Hospital
Santurce, 00912
Puerto RicoSite Not Available
Novartis Investigative Site
Bucuresti, 041914
RomaniaSite Not Available
Novartis Investigative Site
Kazan, 420043
Russian FederationSite Not Available
Novartis Investigative Site
Moscow, 119602
Russian FederationSite Not Available
Novartis Investigative Site
Novosibirsk, 630087
Russian FederationSite Not Available
Novartis Investigative Site
St Petersburg, 197110
Russian FederationSite Not Available
Novartis Investigative Site
St. Petersburg, 197110
Russian FederationSite Not Available
Novartis Investigative Site
Belgrade, 11000
SerbiaSite Not Available
Novartis Investigative Site
Kragujevac, 34000
SerbiaSite Not Available
Novartis Investigative Site
Novi Sad, 21000
SerbiaSite Not Available
Novartis Investigative Site
Bratislava, 833 40
SlovakiaSite Not Available
Novartis Investigative Site
Durban,
South AfricaSite Not Available
Novartis Investigative Site
Rosebank, 2196
South AfricaSite Not Available
Novartis Investigative Site
Malaga, Andalucia 29010
SpainSite Not Available
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainSite Not Available
Novartis Investigative Site
Málaga, Andalucía 29010
SpainSite Not Available
Novartis Investigative Site
Esplugues de Llobregat, Barcelona 08950
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainSite Not Available
Novartis Investigative Site
Valencia, Comunidad Valenciana 46010
SpainSite Not Available
Novartis Investigative Site
Barakaldo, Pais Vasco 48903
SpainSite Not Available
Novartis Investigative Site
Vigo, Pontevedra 36212
SpainSite Not Available
Novartis Investigative Site
Baracaldo, Vizcaya 48903
SpainSite Not Available
Novartis Investigative Site
Madrid, 28006
SpainSite Not Available
Novartis Investigative Site
Lund, 221 85
SwedenSite Not Available
Novartis Investigative Site
Istanbul, TUR 34098
TurkeySite Not Available
Novartis Investigative Site
Ankara, 06500
TurkeySite Not Available
Novartis Investigative Site
Atakum / Samsun, 55139
TurkeySite Not Available
Novartis Investigative Site
Balcova / Izmir, 35340
TurkeySite Not Available
Novartis Investigative Site
Fatih / Istanbul, 34098
TurkeySite Not Available
Novartis Investigative Site
Izmir, 35340
TurkeySite Not Available
Novartis Investigative Site
Konak-Izmir, 35210
TurkeySite Not Available
Novartis Investigative Site
Konak/Izmir, 35210
TurkeySite Not Available
Novartis Investigative Site
Samsun, 55139
TurkeySite Not Available
Novartis Investigative Site
Cherkasy, 18000
UkraineSite Not Available
Novartis Investigative Site
Dnipropetrovsk, 49027
UkraineSite Not Available
Novartis Investigative Site
Kharkiv, 61068
UkraineSite Not Available
Novartis Investigative Site
Kiev, 03110
UkraineSite Not Available
Novartis Investigative Site
Lviv, 79010
UkraineSite Not Available
Novartis Investigative Site
Odesa, 65009
UkraineSite Not Available
Novartis Investigative Site
Vinnytsa, 21029
UkraineSite Not Available
Novartis Investigative Site
West Midlands, Birmingham B4 6NH
United KingdomSite Not Available
Novartis Investigative Site
Edinburgh, EH9 1LF
United KingdomSite Not Available
Novartis Investigative Site
London, NW1 2BU
United KingdomSite Not Available
Novartis Investigative Site
Birmingham, Alabama 35294
United StatesCompleted
UAB Childrens Hospital Harbor Center Neurology Dept
Birmingham, Alabama 35294
United StatesSite Not Available
Novartis Investigative Site
Little Rock, Arkansas 72202
United StatesSite Not Available
Childrens Hospital Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Novartis Investigative Site
Los Angeles, California 90027
United StatesActive - Recruiting
Novartis Investigative Site
San Francisco, California 94115
United StatesCompleted
UCSF
San Francisco, California 94115
United StatesSite Not Available
Novartis Investigative Site
Aurora, Colorado 80045
United StatesSite Not Available
Novartis Investigative Site
North Haven, Connecticut 06473
United StatesSite Not Available
Novartis Investigative Site
Washington, District of Columbia 20010
United StatesSite Not Available
Novartis Investigative Site
Miami, Florida 33136
United StatesCompleted
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Novartis Investigative Site
Naples, Florida 34102
United StatesSite Not Available
Novartis Investigative Site
Orlando, Florida 32819
United StatesSite Not Available
AMO Corporation
Tallahassee, Florida 32312
United StatesSite Not Available
Novartis Investigative Site
Tallahassee, Florida 32312
United StatesCompleted
Novartis Investigative Site
West Palm Beach, Florida 33407
United StatesSite Not Available
Novartis Investigative Site
Atlanta, Georgia 30322
United StatesSite Not Available
Novartis Investigative Site
Chicago, Illinois 60611
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02115
United StatesSite Not Available
Novartis Investigative Site
Detroit, Michigan 48201
United StatesCompleted
Wayne State University
Detroit, Michigan 48201
United StatesSite Not Available
Novartis Investigative Site
New Brunswick, New Jersey 08901
United StatesCompleted
Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United StatesSite Not Available
Novartis Investigative Site
Buffalo, New York 14203
United StatesSite Not Available
Novartis Investigative Site
New York, New York 10021
United StatesSite Not Available
Novartis Investigative Site
Rochester, New York 14642
United StatesSite Not Available
Novartis Investigative Site
Stony Brook, New York 11794
United StatesSite Not Available
Novartis Investigative Site
Syracuse, New York 13210
United StatesSite Not Available
Novartis Investigative Site
Chapel Hill, North Carolina 27599-9500
United StatesSite Not Available
Novartis Investigative Site
Durham, North Carolina 27710
United StatesSite Not Available
Novartis Investigative Site
Columbus, Ohio 43205
United StatesSite Not Available
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania 19104 4399
United StatesSite Not Available
Novartis Investigative Site
Philadelphia, Pennsylvania 19104 4399
United StatesCompleted
Novartis Investigative Site
Greenville, South Carolina 29607
United StatesSite Not Available
Novartis Investigative Site
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Novartis Investigative Site
Dallas, Texas 75390-9034
United StatesSite Not Available
Novartis Investigative Site
Fort Worth, Texas 76104
United StatesSite Not Available
Novartis Investigative Site
Houston, Texas 77030
United StatesSite Not Available
Novartis Investigative Site
San Antonio, Texas 78229
United StatesSite Not Available
Novartis Investigative Site
Salt Lake City, Utah 84108
United StatesCompleted
University of Utah Clinical Trials Office
Salt Lake City, Utah 84108
United StatesSite Not Available
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