Phase
Condition
Multiple Sclerosis
Neurologic Disorders
Memory Loss
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 ofCOVID-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
Hygeia Hospital Tirana
Tirana,
AlbaniaActive - Recruiting
Klinika Mjekesore Nuova, Neurology Clinic
Tirana, 1005
AlbaniaActive - Recruiting
MHAT Puls AD
Blagoevgrad, 2700
BulgariaActive - Recruiting
MHAT "Heart and Brain", EAD
Burgas, 8000
BulgariaActive - Recruiting
Heart and Brain University Hospital
Pleven,
BulgariaActive - Recruiting
MC Exacta Medica OOD
Pleven, 5800
BulgariaActive - Recruiting
MC Vita 1
Pleven,
BulgariaActive - Recruiting
MHAT Avis Medica
Pleven, 5800
BulgariaActive - Recruiting
UMHAT Dr.Georgi Stranski EAD
Pleven, 5800
BulgariaActive - Recruiting
UMHAT Sveti Georgi
Plovdiv, 4002
BulgariaActive - Recruiting
UMHAT "Medica Ruse"
Ruse,
BulgariaActive - Recruiting
CCB Medical Institute Ministry of Interior
Sofia, 1000
BulgariaActive - Recruiting
Diagnostic and Consultative Center Neoclinic
Sofia, 1000
BulgariaActive - Recruiting
MHAT "Sveta Sofia" EOOD
Sofia, 1618
BulgariaActive - Recruiting
MHATNP "Sveti Naum", EAD
Sofia, 1113
BulgariaActive - Recruiting
MHATNPsy Sveti Naum EAD
Sofia, 1113
BulgariaActive - Recruiting
Military Medical Academy
Sofia,
BulgariaActive - Recruiting
Military Medical Academy MHAT
Sofia, 1606
BulgariaActive - Recruiting
UMHAT "Alexandrovska"
Sofia, 1431
BulgariaActive - Recruiting
UMHAT "Alexandrovska" EAD
Sofia, 1431
BulgariaActive - Recruiting
UMHAT "Sveti Ivan Rilski" EAD
Sofia, 1000
BulgariaActive - Recruiting
UMHAT"Tsaritsa Yoanna -ISUL
Sofia,
BulgariaActive - Recruiting
UMHATEM N.Pirogov
Sofia,
BulgariaActive - Recruiting
UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
Varna,
BulgariaActive - Recruiting
Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia
Bogotá,
ColombiaActive - Recruiting
Neurocountry Portoazul S.A.S.
Puerto Colombia,
ColombiaActive - Recruiting
1st Uni Clinic of Tbilisi LEPL
Tbilisi, 0141
GeorgiaActive - Recruiting
Eristavi Experimental Center
Tbilisi,
GeorgiaActive - Recruiting
J.S.C. Curatio Clinic
Tbilisi,
GeorgiaActive - Recruiting
Katsiashvili Emergency Center
Tbilisi,
GeorgiaActive - Recruiting
Khechinashvili University Hospital
Tbilisi,
GeorgiaActive - Recruiting
LTD Aversi Clinic
Tbilisi,
GeorgiaActive - Recruiting
LTD New Hospitals
Tbilisi,
GeorgiaActive - Recruiting
MediClub Georgia LLC
Tbilisi,
GeorgiaActive - Recruiting
Pineo Medical Ecosystem LTD
Tbilisi,
GeorgiaActive - Recruiting
Sarajishvili Neurology Institute
Tbilisi,
GeorgiaActive - Recruiting
Athens Medical Center
Athens,
GreeceActive - Recruiting
Thessaloniki Hosptl
Thessaloníki,
GreeceActive - Recruiting
Kanoria Hospital & Research Centre
Gandhinagar, 382428
IndiaActive - Recruiting
Mallikatte, Kadri
Mangalore, 575002
IndiaActive - Recruiting
Jasleen Hospital
Nagpur,
IndiaActive - Recruiting
Sir Ganga Ram Hospital
New Delhi, 110060
IndiaActive - Recruiting
Ruby Hospital
Pune, 411001
IndiaActive - Recruiting
Indira Gandhi Medical College & Hospital
Shimla, 171001
IndiaActive - Recruiting
Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
Varanasi, 221005
IndiaActive - Recruiting
TSH Advanced Clinical Center
Amman,
JordanActive - Recruiting
Irbid Speciality Hospital
Irbid,
JordanActive - Recruiting
Hotel Dieu de France Hospital
Beirut,
LebanonActive - Recruiting
AUB Medical Center
Hamra, 1107-2020
LebanonActive - Recruiting
Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
Kaunas, 50161
LithuaniaActive - Recruiting
Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra
Klaipėda, 92288
LithuaniaActive - Recruiting
Neurociencias Estudios Clínicos S.C
Culiacán, 80020
MexicoActive - Recruiting
Instituto Jalisciense de Metabolismo, SC
Guadalajara, 44670
MexicoActive - Recruiting
Cliditer S.A de C.V
Mexico City, 06700
MexicoActive - Recruiting
Clinstile SA de CV
Mexico City,
MexicoActive - Recruiting
Grupo medico camino SC
Mexico City, 03310
MexicoActive - Recruiting
Unidad de Investigación en Salud de Chihuahua S.C.
Mexico City, 14050
MexicoActive - Recruiting
Centro de Morelia
Morelia, 58000
MexicoActive - Recruiting
Faicic de RL de CV
Veracruz, 91900
MexicoActive - Recruiting
Sociedad de Metabolismo y Corazon, S.C.
Veracruz, 91900
MexicoActive - Recruiting
Instititute of Emergency Medicine
Chisinau,
Moldova, Republic ofActive - Recruiting
Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
Chisinau,
Moldova, Republic ofActive - Recruiting
The Diomid Gherman Institute of Neurology and Neurosurgery
Chisinau,
Moldova, Republic ofActive - Recruiting
General Hospital Niksic
Nikšić,
MontenegroActive - Recruiting
Clinical Center of Montenegro
Podgorica,
MontenegroActive - Recruiting
Hospital "8 mi Septemvri"
Skopje,
North MacedoniaActive - Recruiting
University Clinic of Neurology
Skopje,
North MacedoniaActive - Recruiting
Hospital Universitario La Paz
Madrid,
SpainActive - Recruiting
Chernihiv Regional Hospital
Chernivtsi,
UkraineActive - Recruiting
Neuro Global, LLC
Ivano-Frankivs'k, 76493
UkraineSite Not Available
Regional Clinical Hospital
Ivano-Frankivs'k, 76008
UkraineActive - Recruiting
Khmelnytsky regional hospital of war veterans
Khmelnytskyi,
UkraineActive - Recruiting
Clinical Hospital #15 of the Podilskyi District of the Kyiv City
Kiev,
UkraineActive - Recruiting
Kyiv City Hospital 4
Kiew,
UkraineActive - Recruiting
"Medbud"
Kyiv, 3037
UkraineSite Not Available
SMART medical center
Kyiv, 4212
UkraineSite Not Available
Odesa Regional Clinical Hospital, Department of Neurosurgery
Odesa,
UkraineActive - Recruiting
Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center
Poltava,
UkraineActive - Recruiting
Ternopil Psycho-Neuro Hospital
Ternopil', 46027
UkraineActive - Recruiting
Regional Clinical Center for Neurosurgery and Neurology
Uzhhorod,
UkraineActive - Recruiting
Xenoscience, Inc., 21st Century Neurology
Phoenix, Arizona 85004
United StatesActive - Recruiting
Bradenton Research Center
Bradenton, Florida 34205
United StatesActive - Recruiting
Reliant Medical Research, LLC
Miami, Florida 33165
United StatesSite Not Available
Collier Neurologic Specialists
Naples, Florida 34105
United StatesActive - Recruiting
Neurology Associates of Ormond Beach
Ormond Beach, Florida 32174
United StatesActive - Recruiting
Consultants in Neurology, Ltd
Northbrook, Illinois 60062
United StatesActive - Recruiting
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