Phase
Condition
Multiple Sclerosis
Memory Loss
Neurologic Disorders
Treatment
Placebo matching IMU-838 tablets
IMU-838 tablets
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patient (age ≥18 to ≤55 years).
- Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
- Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondaryprogressive MS, both defined according to Lublin criteria 1996 and 2014.
- Active disease as defined by Lublin 2014 evidenced prior to Screening by:
- At least 2 relapses in the last 24 months before randomization, or
- At least 1 relapse in the last 12 months before randomization, or
- A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior torandomization.
- Willingness and ability to comply with the protocol.
- Written informed consent given prior to any study-related procedure.
Exclusion
Exclusion Criteria:
- Patients with non-active secondary progressive MS and primary progressive MS.
- Any disease other than MS that may better explain the signs and symptoms, includinghistory of complete transverse myelitis.
- Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associatedencephalomyelitis
- Any active and uncontrolled coexisting autoimmune disease, other than MS (except fortype 1 diabetes mellitus and inflammatory bowel disease)
- Use of experimental/investigational drug (with the exception of COVID-19 vaccinesapproved by emergency use authorization) and/or participation in drug clinical studieswithin 6 months prior to Screening
- Previous or current use of MS treatments lifelong, or within a pre-specified timeperiod.
- Use of the pre-specified concomitant medications.
- Clinically significantly abnormal and pre-specified lab values.
- History of chronic systemic infections within 6 months before the date of informedconsent.
- Diagnosis or suspected liver function impairment, which may cause fluctuating liverfunction tests during this study.
- Known history of nephrolithiasis or underlying condition with a strong association ofnephrolithiasis.
- History or clinical diagnosis of gout.
- History or presence of any major medical or psychiatric illness
- Substantial medical condition that could create undue risk to the patient, couldaffect adherence with the study protocol or could undesirably affect study outcomes
Study Design
Study Description
Connect with a study center
Erebouni Medical Center
Yerevan, 0087
ArmeniaActive - Recruiting
Heratsi Hospital Complex 1
Yerevan, 0025
ArmeniaActive - Recruiting
UCC of Rep of Srpska
Banja Luka,
Bosnia and HerzegovinaActive - Recruiting
Cantonal Hospital Bihac Dr. Irfan Ljubijankic
Bihać, 77000
Bosnia and HerzegovinaActive - Recruiting
University Clinical Center Sarajevo
Sarajevo, 71000
Bosnia and HerzegovinaActive - Recruiting
University Clinical Center of Sarajevo
Sarajevo, 71000
Bosnia and HerzegovinaActive - Recruiting
University Clinical Center Tuzla
Tuzla, 75000
Bosnia and HerzegovinaActive - Recruiting
Astra Clinic
Tallinn,
EstoniaActive - Recruiting
Post-Graduation Institute of Medical Education and Research (PGIMER)
Chandigarh, 160012
IndiaActive - Recruiting
Fortis Memorial Research Institute
Gurugramam, 122002
IndiaActive - Recruiting
Dr Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010
IndiaActive - Recruiting
All India Institute of Medical Sciences
New Delhi, 110029
IndiaActive - Recruiting
GB Pant Institute of Postgraduate Medical Education and Research
New Delhi, 110056
IndiaActive - Recruiting
SRI Guru Ram Das Institute of Medical Sciences and Research
Punjabi Bagh, 143006
IndiaActive - Recruiting
DKS PGI
Raipur, 492001
IndiaActive - Recruiting
Centro de Investig. Médicas
Lima, 15801
PeruActive - Recruiting
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
Katowice, 40123
PolandActive - Recruiting
Neuro-Medic Janusz Zbrojkiewicz
Katowice, 40686
PolandActive - Recruiting
Indywidualna Praktyka Lekarska prof. Konrad Rejdak
Lublin, 20-410
PolandActive - Recruiting
NZOZ Neuromed
Lublin, 20-064
PolandActive - Recruiting
Instytut Zdrowia Boczarska
Oświęcim, 32-600
PolandActive - Recruiting
NZOZ Hertmanowskiej
Plewiska, 62-064
PolandActive - Recruiting
NZOZ Neuro-Kard
Poznań, 61-853
PolandActive - Recruiting
Centrum Medyczne NeuroProtect
Warsaw, 01684
PolandActive - Recruiting
FutureMeds Warszawa Centrum
Warsaw,
PolandActive - Recruiting
Centrum Med. Ibismed
Zabrze,
PolandActive - Recruiting
Elias University Emergency Hospital
Bucharest, 011461
RomaniaActive - Recruiting
SC Sana Monitoring SRL
Bucharest, 011025
RomaniaActive - Recruiting
Spitalul clinic CF Constanta
Constanţa, 900123
RomaniaActive - Recruiting
Asociatia Comunitatea Oamenilor
Craiova, 200157
RomaniaActive - Recruiting
Clubul Sanatatii SRL
Câmpulung, 115100
RomaniaActive - Recruiting
Aria Clinic SRL
Sibiu, 550052
RomaniaActive - Recruiting
Neuro Therapy
Timişoara, 300425
RomaniaSite Not Available
Spit Jud Branzeu TIM Neuro
Timişoara, 300723
RomaniaActive - Recruiting
Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade, 11000
SerbiaActive - Recruiting
Klinicko bolnicki centar Zvezdara
Belgrade, 11000
SerbiaActive - Recruiting
Opsta bolnica Medicinski sistem Beograd
Belgrade, 11000
SerbiaActive - Recruiting
Vojnomedicinska akademija
Belgrade, 11000
SerbiaActive - Recruiting
Univerzitetski Klinicki centar Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
Univerzitetski Klinicki centar Nis
Niš, 18000
SerbiaActive - Recruiting
Hsptl Sveti Vracevi
Novi Kneževac,
SerbiaActive - Recruiting
General Hospital Uzice
Užice, 31000
SerbiaActive - Recruiting
Klinicko Bolnicki centar Zemun
Zemun, 11080
SerbiaActive - Recruiting
Opsta bolnica Djordje Jovanovic Zrenjanin
Zrenjanin, 23000
SerbiaActive - Recruiting
Acibadem Adana Hospital
Adana, 01130
TurkeyActive - Recruiting
Adana Baskent Hospital
Adana, 01250
TurkeyActive - Recruiting
Baskent University Ankara Hospital
Ankara, 06490
TurkeyActive - Recruiting
Bezmialem Vakif University Hospital
Istanbul, 34093
TurkeyActive - Recruiting
Haydar Pasa Num. EAH
Istanbul,
TurkeyActive - Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
TurkeyActive - Recruiting
Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
Istanbul, 34785
TurkeyActive - Recruiting
T.C. Ministry of Health Istanbul Haseki Training and Research Hospital
Istanbul, 34250
TurkeyActive - Recruiting
Kocaeli University Research and Application Hospital
Kocaeli, 41000
TurkeyActive - Recruiting
T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital
Kütahya, 43100
TurkeyActive - Recruiting
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, 45030
TurkeyActive - Recruiting
19 Mayis University Medical Faculty Hospital Health Application and Research Center
Samsun, 55200
TurkeyActive - Recruiting
Namik Kemal Uni Hospital
Tekirdağ, 59100
TurkeyActive - Recruiting
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
Zonguldak, 67000
TurkeyActive - Recruiting
Communal noncommercial enterprise "First Cherkasy City Hospital"
Cherkasy, 18009
UkraineSite Not Available
MS Diagnosis Treatment Center
Cherkasy,
UkraineActive - Recruiting
Chernihiv City Hospital 4
Chernihiv,
UkraineActive - Recruiting
"University Clinic" of Dnipro State Medical University, Department of Neurology
Dnipro, 49038
UkraineSite Not Available
Dnipro City Hospital 6
Dnipro,
UkraineActive - Recruiting
Municipal Institution "Dnipropetrovsk Regional Rehabilitation Hospital" of Dnipropetrovsk Regional Council"
Dnipro, 49000
UkraineActive - Recruiting
Ukrainian State Research Institute of Medico-Social Problems of Disability
Dnipro, 49027
UkraineSite Not Available
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1
Kremenchuk, 39623
UkraineActive - Recruiting
1 Private Clinic Medical Center
Kyiv,
UkraineActive - Recruiting
Dopomoga Plus medical center
Kyiv,
UkraineSite Not Available
State Institution "National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine
Kyiv, 03115
UkraineActive - Recruiting
Volyn Reg Clin Hospital
Luts'k, 43005
UkraineSite Not Available
5 City Clin Hospital
Lviv, 79013
UkraineSite Not Available
Lviv Regional Central Hospital
Lviv, 79010
UkraineSite Not Available
Communal institution "City Clinical Hospital №3" of Poltava City Council
Poltava, 36000
UkraineActive - Recruiting
City Clinical Hospital 2
Rivne,
UkraineSite Not Available
Sumy Reg Clinical Hospital
Sumy,
UkraineActive - Recruiting
Salutem
Vinnytsia, 21018
UkraineActive - Recruiting
LCC Medical center INET-09
Zaporizhzhya, 69001
UkraineSite Not Available
Zaporizhia Med
Zaporizhzhya,
UkraineSite Not Available
Zaporizhia Regional Clinic Hospital
Zaporizhzhya,
UkraineSite Not Available
Zaporizhzhya City Hospital 6
Zaporizhzhya,
UkraineSite Not Available
Zaporizhzhya Hospital 9
Zaporizhzhya,
UkraineSite Not Available
Royal Devon Uni NHS
Exeter, EX2 5DW
United KingdomActive - Recruiting
Royal Hallamshire Hospital
Sheffield,
United KingdomActive - Recruiting
HonorHealth Research Institute - Bob Bove Neuroscience Institute
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Neuro of Central Florida
Altamonte Springs, Florida 32714
United StatesActive - Recruiting
Healthcare Innovations
Coral Springs, Florida 33067
United StatesActive - Recruiting
Homestead Associates
Miami, Florida 33032
United StatesActive - Recruiting
Premier Clinical Research
Miami, Florida 33122
United StatesActive - Recruiting
Baptist Health Lexington
Nicholasville, Kentucky 40356
United StatesActive - Recruiting
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.