Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
- Conditions
- Progressive Multiple Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05441488
- Lead Sponsor
- AB Science
- Brief Summary
To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.
- Detailed Description
Masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (MS). This is a multicenter, double-blind, randomized, placebo-controlled, comparative study of oral masitinib in the treatment of patients with progressive MS who were progressing but not clinically active.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Masitinib (4.5) Masitinib (4.5) Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Placebo Placebo Participants receive a matched dose placebo, given orally twice daily.
- Primary Outcome Measures
Name Time Method Time to confirmed progression 96 weeks Time to disability progression, confirmed by two consecutive visits, wherein progression of disability is measured by the Expanded Disability Status Scale (EDSS) with progression defined as a 1-point worsening for baseline EDSS score ≤5.5, or 0.5-point worsening for baseline EDSS score \>5.5.
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS provides a total score on a scale that ranges from 0 to 10, in 0.5-point increments, with higher scores indicating greater disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.
- Secondary Outcome Measures
Name Time Method Time to Expanded Disability Status Scale (EDSS) score of 7.0 96 weeks Time to reach EDSS score of 7 from baseline up to week 96, wherein EDSS score of ≥7.0 represents wheelchair dependency.
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS provides a total score on a scale that ranges from 0 to 10, in 0.5-point increments, with higher scores indicating greater disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.Multiple Sclerosis Quality of Life (MSQOL)-54 96 weeks Change in quality of life assessment instrument MSQOL-54 The MS Quality of Life Instrument (MSQoL-54) is a structured self-report questionnaire that is used to assess the impact of MS on the individual's well-being. It consists of 52 items combined in 12 subscales, and two single items. Higher scores indicate a better quality of life.
Overall Change in Expanded Disability Status Scale (EDSS) Score 96 weeks Change from baseline on the EDSS, calculated using repeated measures methodology on all time points measured over 96 weeks (i.e., a population-averaged score comprising consecutive data points from each patient).
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS provides a total score on a scale that ranges from 0 to 10, in 0.5-point increments, with higher scores indicating greater disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.Brain Magnetic Resonance Imaging Assessments 96 weeks Change in baseline brain volume and lesions will be measured and assessed
Trial Locations
- Locations (37)
Service de Neurologie Hôpital Henri-Mondor
🇫🇷Créteil, France
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hôpital Pasteur - CHU de Nice
🇫🇷Nice, France
Hôpital Roger Salengro
🇫🇷Lille, France
Nzoz Neuro-Medic
🇵🇱Katowice, Poland
Athens Naval Hospital
🇬🇷Athens, Greece
NZOZ Neuro-Kard
🇵🇱Poznań, Poland
Clinical Best Solutions
🇵🇱Warsaw, Poland
Eginition Hospital, Athens University Medical School
🇬🇷Athens, Greece
Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1
🇺🇦Ternopil, Ukraine
Centrum Neurologii Krzysztof Selmaj
🇵🇱Łódź, Poland
Lviv Regional Clinical Hospital
🇺🇦Lviv, Ukraine
Centre Hospitalier Universitaire de Rouen
🇫🇷Rouen, France
AHEPA University Hospital, Aristotle University of Thessaloniki
🇬🇷Thessaloníki, Greece
General University Hospital of Larissa
🇬🇷Larissa, Greece
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"
🇮🇹Catania, Italy
Private Clinic ELPIS
🇬🇷Volos, Greece
NOVI-MED
🇵🇱Ksawerów, Poland
Generała Jarosława Dąbrowskiego
🇵🇱Oświęcim, Poland
State Budgetary Institution of Health of the City of Moscow City Polyclinic #2
🇷🇺Moscow, Russian Federation
City Hospital No. 40 Kurortny District
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario de Cruces
🇪🇸Bilbao, Spain
Gregorio Marañón General University Hospital
🇪🇸Madrid, Spain
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Centrum för neurologi
🇸🇪Stockholm, Sweden
Salutem Medical Center
🇺🇦Vinnytsia, Ukraine
Centre Hospitalier Universitaire de Strasbourg
🇫🇷Strasbourg, France
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Perm Regional Clinical Hospital
🇷🇺Perm, Russian Federation
Centre Hospitalier Universitaire Nimes - Service de Neurologie
🇫🇷Nîmes, France
Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye
🇫🇷Poissy, France
Le Centre hospitalier universitaire de Poitiers
🇫🇷Poitiers, France
LLC "Center of socially significant diseases"
🇷🇺Saint Petersburg, Russian Federation
Centre Hospitalier Universitaire Toulouse
🇫🇷Toulouse, France
Hospital del Mar
🇪🇸Barcelona, Spain
NZOZ Neuro-Med
🇵🇱Lublin, Poland
Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise
🇺🇦Rivne, Ukraine