Studie k hodnocení účinnosti, bezpečnosti a snášenlivosti IMU-838 u pacientů s recidivující roztroušenou sklerózou (ENSURE-1)
Multicentrická, randomizovaná, dvojitě zaslepená studie fáze 3 k vyhodnocení účinnosti, bezpečnosti a snášenlivosti IMU-838 versus placebo u dospělých s recidivující roztroušenou sklerózou (ENSURE-1)
Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Tirana, Albánie, 1005
- Klinika Mjekesore Nuova, Neurology Clinic
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Tirana, Albánie
- Hygeia Hospital Tirana
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Algiers, Alžírsko, 16000
- University Hospital Center Mustapha Pacha, Algiers
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Annaba, Alžírsko, 23000
- University Hospital Center Ibn Sina, Annaba
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Oran, Alžírsko, 31000
- University Hospital Center of Oran
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Blagoevgrad, Bulharsko, 2700
- MHAT Puls AD
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Burgas, Bulharsko, 8000
- MHAT "Heart and Brain", EAD
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Pleven, Bulharsko, 5800
- MC Exacta Medica OOD
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Pleven, Bulharsko, 5800
- MHAT Avis Medica
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Pleven, Bulharsko, 5800
- UMHAT Dr.Georgi Stranski EAD
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Pleven, Bulharsko
- Heart and Brain University Hospital
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Pleven, Bulharsko
- MC Vita 1
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Plovdiv, Bulharsko, 4002
- UMHAT Sveti Georgi
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Plovdiv, Bulharsko, 4001
- UMHAT "Kaspela"EOOD
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Plovdiv, Bulharsko, 4002
- UMHAT "Pulmed" Ltd
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Rousse, Bulharsko
- UMHAT "Medica Ruse"
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Sofia, Bulharsko, 1431
- UMHAT "Alexandrovska"
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Sofia, Bulharsko, 1431
- UMHAT "Alexandrovska" EAD
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Sofia, Bulharsko
- Military Medical Academy
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Sofia, Bulharsko, 1606
- Military Medical Academy MHAT
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Sofia, Bulharsko, 1000
- CCB Medical Institute Ministry of Interior
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Sofia, Bulharsko, 1000
- Diagnostic and Consultative Center Neoclinic
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Sofia, Bulharsko, 1000
- UMHAT "Sveti Ivan Rilski" EAD
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Sofia, Bulharsko, 1113
- MHATNP "Sveti Naum", EAD
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Sofia, Bulharsko, 1113
- MHATNPsy Sveti Naum EAD
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Sofia, Bulharsko, 1618
- MHAT "Sveta Sofia" EOOD
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Sofia, Bulharsko
- UMHAT"Tsaritsa Yoanna -ISUL
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Sofia, Bulharsko
- UMHATEM N.Pirogov
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Varna, Bulharsko
- UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
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Tbilisi, Gruzie
- LTD Aversi Clinic
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Tbilisi, Gruzie, 0141
- 1st Uni Clinic of Tbilisi LEPL
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Tbilisi, Gruzie
- Eristavi Experimental Center
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Tbilisi, Gruzie
- J.S.C. Curatio Clinic
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Tbilisi, Gruzie
- Khechinashvili University Hospital
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Tbilisi, Gruzie
- LTD New Hospitals
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Tbilisi, Gruzie
- MediClub Georgia LLC
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Tbilisi, Gruzie
- Sarajishvili Neurology Institute
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Tbilisi, Gruzie
- JSC "Jerarsi"
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Tbilisi, Gruzie
- Pineo Medical Ecosystem LTD
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Bangalore, Indie, 560092
- Medstar Speciality Hospital
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Mangalore, Indie, 575002
- Mallikatte, Kadri
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Nagpur, Indie
- Jasleen Hospital
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New Delhi, Indie, 110060
- Sir Ganga Ram Hospital
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Pune, Indie, 411001
- Ruby Hospital
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Shimla, Indie, 171006
- Atal Institute of Medical Super Specialities (AIMSS)
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Varanasi, Indie, 221005
- Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
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Amman, Jordán, 11942
- Jordan University Hospital
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Amman, Jordán, 11196
- Istiklal Hospital
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Amman, Jordán
- TSH Advanced Clinical Center
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Irbid, Jordán
- Irbid Speciality Hospital
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Beirut, Libanon
- Hotel Dieu de France Hospital
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Hamra, Libanon, 1107-2020
- AUB Medical Center
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Kaunas, Litva, 50161
- Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
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Culiacán, Mexiko, 80020
- Neurociencias Estudios Clínicos S.C
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Guadalajara, Mexiko, 44670
- Instituto Jalisciense de Metabolismo, SC
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Mexico City, Mexiko, 14050
- Unidad de Investigación en Salud de Chihuahua S.C.
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Mexico City, Mexiko
- Clinstile SA de CV
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Mexico City, Mexiko, 03310
- Grupo medico camino SC
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Mexico City, Mexiko, 06700
- Consultorio Médico Expert Brain Clinic
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Morelia, Mexiko, 58000
- Centro de Morelia
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Veracruz, Mexiko, 91900
- Sociedad de Metabolismo y Corazon, S.C.
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Veracruz, Mexiko, 91900
- Faicic de RL de CV
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Chisinau, Moldavsko
- Instititute of Emergency Medicine
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Chisinau, Moldavsko
- Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
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Chisinau, Moldavsko
- The Diomid Gherman Institute of Neurology and Neurosurgery
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Münster, Německo, 48149
- University Hospital Muenster, Institute Translational Neurology dept. Neurology
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Lublin, Polsko, 20-064
- NZOZ Neuromed M. i M. Nastaj Sp. P.
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Barnaul, Rusko, 656045
- City Hospital #5, Barnaul
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Barnaul, Rusko, 656906
- Profimed LLC
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Bryansk, Rusko, 241033
- Bryansk Regional Hospital 1
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Chelyabinsk, Rusko, 454021
- Regional Clinical Hospital 3
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Krasnoyarsk, Rusko, 660037
- Federal Siberian Scientific and Clinical Centre of Federal Medical and Biological Agency
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Kursk, Rusko, 305007
- Kursk Regional Clinical Hospital
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Nizhny Novgorod, Rusko, 603076
- Medis LLC
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Novosibirsk, Rusko, 630004
- Sibneiromed LLC
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Novosibirsk, Rusko, 630007
- SDMCH SDMC of FMBA of Russia
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Perm, Rusko, 614045
- Perm State Medical University n.a. Acad. E. A. Vagner
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Samara, Rusko, 443095
- Samara regional clinical hospital n. a. V. L. Seredavin
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Yekaterinburg, Rusko, 620102
- Sverdlovsk Regional Clinical Hospital #1
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Skopje, Severní Makedonie
- Hospital "8 mi Septemvri"
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Skopje, Severní Makedonie
- University Clinic of Neurology
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Arizona
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Phoenix, Arizona, Spojené státy, 85004
- Xenoscience, Inc., 21st Century Neurology
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California
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West Hollywood, California, Spojené státy, 90048
- Regina Berkovich MD, PhD Inc. MS Neurology
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Florida
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Bradenton, Florida, Spojené státy, 34205
- Bradenton Research Center
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Naples, Florida, Spojené státy, 34105
- Collier Neurologic Specialists
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Ormond Beach, Florida, Spojené státy, 32174
- Neurology Associates of Ormond Beach
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Illinois
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Northbrook, Illinois, Spojené státy, 60062
- Consultants in Neurology, Ltd
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Chernihiv, Ukrajina, 14029
- Communal Non-Commercial Enterprise "Chernihiv Regional Hospital",Department of Neurology
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Chernivtsi, Ukrajina, 58023
- Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
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Chernivtsi, Ukrajina
- Chernihiv Regional Hospital
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Ivano-Frankivsk, Ukrajina, 76008
- Regional Clinical Hospital
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Ivano-Frankivsk, Ukrajina, 76493
- Neuro Global, LLC
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Khmelnytskyi, Ukrajina
- Khmelnytsky regional hospital of war veterans
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Kiev, Ukrajina
- Clinical Hospital #15 of the Podilskyi District of the Kyiv City
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Kyiv, Ukrajina, 3037
- "Medbud"
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Kyiv, Ukrajina, 4212
- SMART medical center
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Kyiv, Ukrajina
- Kyiv City Hospital 4
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Odesa, Ukrajina
- Odesa Regional Clinical Hospital, Department of Neurosurgery
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Poltava, Ukrajina
- Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center
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Ternopil, Ukrajina, 46027
- Ternopil Psycho-Neuro Hospital
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Uzhhorod, Ukrajina
- Regional Clinical Center for Neurosurgery and Neurology
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Nikšić, Černá Hora
- General Hospital Niksic
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Podgorica, Černá Hora
- Clinical Center of Montenegro
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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Male or female patient (age ≥18 to ≤55 years).
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Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
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Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
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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 to randomization.
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Willingness and ability to comply with the protocol.
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Written informed consent given prior to any study-related procedure.
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, including history of complete transverse myelitis.
- Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
- Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
- Use of experimental/investigational drug (with the exception ofCOVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
- Previous or current use of MS treatments lifelong, or within a pre-specified time period.
- 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 informed consent.
- Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
- Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
- 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, could affect adherence with the study protocol or could undesirably affect study outcomes
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: IMU-838
IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH. Formulation: Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning. |
Patients are randomized to IMU-838 or placebo in ratio 1:1
Ostatní jména:
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Komparátor placeba: Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838. |
Patients are randomized to IMU-838 or placebo in ratio 1:1
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
Časové okno: 72 weeks
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Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks. |
72 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effect of IMU-838 versus placebo on volume of new T2 lesions
Časové okno: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions. Mean difference between IMU-838- and placebo in changes of the volume of new MRI T2 lesions over 24-weeks of treatment in the double-blind period. |
72 weeks
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Effect of IMU-838 versus placebo on disability progression
Časové okno: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on disability progression. Survival analysis of time to 12-week confirmed disability progression, as measured on Expanded Disability Status Scale during the double-blind period, censored at maximum 72-weeks. |
72 weeks
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Effect of IMU-838 versus placebo on cognitive performance
Časové okno: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on cognitive performance. Survival analysis of time to confirmed clinically relevant changes on Symbol Digit Modalities Test during the double-blind period, censored at maximum 72-weeks. |
72 weeks
|
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Effect of IMU-838 versus placebo on whole brain atrophy
Časové okno: 72 weeks
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To evaluate the effect of IMU-838 versus placebo on whole brain atrophy. Difference in the mean of the percentage change on the whole brain volume between IMU-838 and placebo during the 72-weeks double-blind period. |
72 weeks
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Safety of IMU-838 versus placebo
Časové okno: 72 weeks
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To evaluate safety and tolerability of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations. |
72 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Robert J. Fox, MD, Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P3-IMU-838-RMS-01
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