210
Participants
Start Date
January 28, 2019
Primary Completion Date
April 24, 2020
Study Completion Date
December 31, 2029
IMU-838 (30 mg/day)
"* Main treatment period: All patients will receive half the assigned dose during the first 7 days of the main treatment period (one 15 mg tablet IMU-838 daily) and then start taking the full assigned dose from Day 7 onwards (two 15 mg tablets IMU-838 once daily).~* Optional extended treatment period (optional): Participants who were re-randomized to a 30 mg/day dose will take the full assigned dose which consists of two 15 mg tablets IMU-838 once daily."
IMU-838 (45 mg/day)
"* Main treatment period: All patients will receive half the assigned dose during the first 7 days of the main treatment period (one 22.5 mg tablet per day) and then start taking the full assigned dose from Day 7 onwards (two 22.5 mg tablets once daily).~* Optional extended treatment period (optional): Participants who were re-randomized to a 45 mg/day dose will take the full assigned dose of two 22.5 mg tablets IMU-838 once daily."
Placebo
"* Main treatment period (Cohort 1 and Cohort 2): All patients will receive 1 tablet per day during the first 7 days of the main treatment period and then start taking 2 tablets once daily from Day 7 onwards.~* Optional extended treatment period: Placebo not applicable as participants were re-randomized to a 30 mg/day dose or a 45 mg/day dose."
IMU-838 (10 mg/day)
"* Main treatment period for Cohort 2: All patients will receive half the assigned dose during the first 7 days of the main treatment period (one 5 mg tablet per day) and then start taking the full assigned dose from Day 7 onwards (two 5 mg tablets once daily).~* Optional extended treatment period (not applicable to Cohort 2): IMU-838 10 mg/day not applicable."
"MHATNP Sveti Naum EAD, Neurology Clinic for Movement Disorders, First Department of Neurology Diseases", Sofia
"MHATNPsy Sveti Naum EAD, Intensive Therapy Clinic Of Neurology Diseases", Sofia
"DCC Neoclinic EAD, Cabinet Neurology Diseases", Sofia
"UMHAT Alexandrovska EAD, Clinic of Neurology Diseases, Department of Inherited Degenerative and Immunoinflamatori Diseases at Peripheral Nervous System", Sofia
"UMHAT Sveti Ivan Rilski EAD Sofia Clinic of Neurological Diseases", Sofia
"UMHATAlexandrovskaEAD, Department of Degenerative and Immunoinflamatory Disease of the Central Nervous System", Sofia
Central Clinical Base-Medical Institute - Ministry of Interior, Neurology Clinic, Sofia
Military Medical Academy - Sofia, Clinic of Neurology Diseases, Sofia
Military Medical Academy, Clinic of Functional Diagnostics of Nevous System, Sofia
MHAT Pulse AD, Department of Neurology Diseases, Blagoevgrad
"UMHAT Kaspela EOOD, Department of Neurology Diseases", Plovdiv
"UMHAT Dr.Georgi Stranski EAD Pleven Department of Professional Diseases", Pleven
"MHAT Heart and brain EAD Pleven Department of Neurology Diseases", Pleven
"UMHAT Kanev Ruse, Department of General and Vascular Neurology", Rousse
"UMHAT Sveta Marina EAD, First Neurology Clinic", Varna
Chernihiv Regional Hospital, Department of Neurology, Chernihiv
Vinnytsya Regional Psychoneurology Hospital n.a. Yushchenko, Department of Neurology #3, Vinnytsia
Poltava Regional Clinical Hospital n.a. Sklifosovskyi, Department of Neurology, Poltava
Volyn Regional Clinical Hospital, Department of Neurology, Lutsk
Dnipropetrovsk Municipal Hospital #5, Neurological Department of the inflammatory and demyelinating diseases of CNS, Dnipro
Ukrainian State Research Institute of Medical and Social Problems of Disability of MOH of Ukraine, Dnipro
Kharkiv Regional Clinical Hospital, Department of Neurology, Kharkiv
Institute of Neurology, Psychiatry and Narcology NAMSU, Kharkiv
City Clinical Hospital #2, Department of Neurology, Zaporizhzhya
Zaporizhzhya Regional Clinical Hospital, Department of Neurology #1, Zaporizhzhya
Regional Clinical Hospital, Department of vascular Neurology, Ivano-Frankivsk
Regional Clinical Centre of Neurosurgery and Neurology, Department #2, Uzhhorod
Spitalul Clinic Cai Ferate Constanta, Constanța
Nasz Lekarz Ośrodek Badań Klinicznych, Bydgoszcz
Specjalistyczna Praktyka Lekarska Paweł Bochniak, Bydgoszcz
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak, Lublin
BioResearch Group Sp. Z o.o, Nadarzyn
Centrum Medyczne NeuroProtect, Warsaw
S.C. Sana Monitoring Srl, Bucharest
Spitalul Universitar Elias Bucharesti, Bucharest
S.C. Quantum Medical Center Srl, Bucharest
Spitalul Clinic Colentina Bucharest, Neurologie 2, Bucharest
Kyiv City Clinical Hospital #4, Department of Neurology, Kyiv
Lead Sponsor
Immunic AG
INDUSTRY