Multiple Sclerosis Clinical Trial
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Summary
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Full Description
The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.
Eligibility Criteria
Eligibility Criteria:
To be eligible to participate in this trial, patients must meet all of the following criteria:
Completed one of the parent trials
Does not have a condition that would require withdrawal from one of the parent trials
Has no conditions requiring treatment with a prohibited concomitant medication
Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
At Baseline (Day 1)
CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
Acceptable methods of birth control in this study are the following:
Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
Placement of an intrauterine device (IUD)
Placement of an intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomised partner
Sexual abstinence.
Exclusion Criteria:
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There are 162 Locations for this study
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85013, United States
Berkeley California, 94705, United States
Fresno California, 93710, United States
Long Beach California, 90806, United States
Sacramento California, 95817, United States
San Francisco California, 94158, United States
Maitland Florida, 32751, United States
Port Charlotte Florida, 33952, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33609, United States
Golden Valley Minnesota, 55422, United States
Las Vegas Nevada, 89106, United States
Raleigh North Carolina, 27607, United States
Westerville Ohio, 43801, United States
Knoxville Tennessee, 37922, United States
Lubbock Texas, 79410, United States
Round Rock Texas, 78681, United States
Kirkland Washington, 98034, United States
Gomel , 24602, Belarus
Grodno , 23001, Belarus
Minsk , 22002, Belarus
Minsk , 22011, Belarus
Minsk , 22011, Belarus
Vitebsk , 21002, Belarus
Vitebsk , 21003, Belarus
Brugge , 8000, Belgium
Bruxelles , 1200, Belgium
Montegnee , 4420, Belgium
Banja Luka , 51000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Sofia , 1113, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1606, Bulgaria
Osijek , 31000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Tallinn , 10138, Estonia
Tallinn , 10617, Estonia
Tartu , EE-51, Estonia
Tbilisi , 0112, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0177, Georgia
Tbilisi , 0179, Georgia
Leipzig , 04103, Germany
Potsdam , 14471, Germany
Ulm , 89079, Germany
Athens , 10676, Greece
Athens , 115 2, Greece
Athens , 11525, Greece
Thessaloniki , 57010, Greece
Budapest , 1145, Hungary
Budapest , 1204, Hungary
Esztergom , 2500, Hungary
Kistarcsa , 2143, Hungary
Nyiregyhaza , 4400, Hungary
Catania , 95123, Italy
Cefalu , 90015, Italy
Milan , 20122, Italy
Montichiari , 25018, Italy
Roma , 00133, Italy
Riga , LV-10, Latvia
Riga , LV100, Latvia
Kaunas Kauno Apskritis, LT-50, Lithuania
Klaipeda , LT-92, Lithuania
Chisinau , 2004, Moldova, Republic of
Chisinau , 2028, Moldova, Republic of
Chisinau , 2028, Moldova, Republic of
Christchurch , 8011, New Zealand
Hamilton , 2001, New Zealand
Warszawa Mazowieckie, 05-07, Poland
Bialystok , 15-42, Poland
Bydgoszcz , 85-79, Poland
Czeladz , 41-25, Poland
Gdansk , 80-80, Poland
Jaroslaw , 37-50, Poland
Katowice , 40-55, Poland
Katowice , 40-59, Poland
Katowice , 40-65, Poland
Katowice , 40-74, Poland
Kielce , 25-72, Poland
Konstancin Jeziorna , 05-51, Poland
Krakow , 31-30, Poland
Lublin , 20-05, Poland
Lublin , 20-71, Poland
Lublin , 20-71, Poland
Lódzkie , 90-32, Poland
Mazowieckie , 02-09, Poland
Olsztyn , 10-56, Poland
Plewiska , 62-06, Poland
Pomorskie , 80-29, Poland
Poznan , 60-35, Poland
Poznan , 61-85, Poland
Rybnik , 44-20, Poland
Rzeszow , 35-32, Poland
Szczecin , 70-11, Poland
Warminsko-mazurskie , 10-44, Poland
Warsaw , 00-73, Poland
Warszawa , 01-69, Poland
Warszawa , 02-50, Poland
Warszawa , 02-95, Poland
Warszawa , 04-14, Poland
Braga , 4710-, Portugal
Coimbra , 3000-, Portugal
Torres Vedras , 2560-, Portugal
Brasov , 50012, Romania
Bucharest , 02232, Romania
Bucharest , 20125, Romania
Bucharest , 20125, Romania
Campulung , 11510, Romania
Cluj Napoca , 40001, Romania
Cluj-Napoca , 40034, Romania
Constanta , 90012, Romania
Timisoara , 30073, Romania
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Kragujevac , 34000, Serbia
Nis , 18000, Serbia
Bratislava , 833 0, Slovakia
Lucenec , 984 0, Slovakia
Trnava , 91775, Slovakia
Pretoria , 0040, South Africa
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Bilbao , 48013, Spain
Girona , 17190, Spain
Madrid , 28006, Spain
Majadahonda , 28222, Spain
Pamplona/ Navarra , 31008, Spain
San Sebastian , 20014, Spain
Sant Joan Despí , 08970, Spain
Sevillla , 41009, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Goteborg , SE-41, Sweden
Cherkasy , 18009, Ukraine
Chernihiv , 14001, Ukraine
Chernihiv , 14029, Ukraine
Chernivtsi , 58018, Ukraine
Dnipropetrovsk , 49027, Ukraine
Dnipropetrovsk , 49027, Ukraine
Ivano Frankivsk , 76008, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kharkiv , 61018, Ukraine
Kharkiv , 61022, Ukraine
Kharkiv , 61176, Ukraine
Kherson , 73000, Ukraine
Kyiv , 03115, Ukraine
Kyiv , 04107, Ukraine
Kyiv , 3110, Ukraine
Kyiv , 3110, Ukraine
Lutsk , 43024, Ukraine
Lviv , 79010, Ukraine
Lviv , 79044, Ukraine
Odesa , 65009, Ukraine
Odesa , 65025, Ukraine
Odesa , 65117, Ukraine
Poltava , 36011, Ukraine
Uzhhorod , 88018, Ukraine
Vinnytsia , 21005, Ukraine
Zaporizhia , 69065, Ukraine
Zaporizhzhia , 69600, Ukraine
Zaporizhzhya , 69035, Ukraine
Zhytomyr , 10008, Ukraine
East Sussex , BN2 5, United Kingdom
Inverness , IV2 3, United Kingdom
Sheffield , S10 2, United Kingdom
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