Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01433497 |
Recruitment Status :
Completed
First Posted : September 14, 2011
Last Update Posted : April 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Relapse Free | Drug: Masitinib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 656 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis |
Actual Study Start Date : | August 2011 |
Actual Primary Completion Date : | September 2019 |
Actual Study Completion Date : | February 2020 |

Arm | Intervention/treatment |
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Experimental: Experimental Arm A
Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.
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Drug: Masitinib
Other Name: AB1010 |
Experimental: Experimental Arm B
Participants receive masitinib (4.5 mg/kg/day), given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment.
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Drug: Masitinib
Other Name: AB1010 |
Placebo Comparator: Placebo Comparator A
Participants receive placebo given orally twice daily.
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Drug: Placebo
Other Name: Placebo Oral Tablet |
Placebo Comparator: Placebo Comparator B
Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.
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Drug: Placebo
Other Name: Placebo Oral Tablet |
- EDSS [ Time Frame: 96 weeks ]Expanded Disability Status Scale (EDSS) after 96 weeks of treatment
- MSQOL-54 [ Time Frame: 96 weeks ]Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
- MSFC [ Time Frame: 96 weeks ]Multiple Sclerosis Functional Composite (MSFC)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main inclusion criteria:
- Patient suffering from either primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion according to the revised McDonald's criteria.
Main exclusion criteria:
- Patient suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433497
Bulgaria | |
"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment | |
Sofia, Bulgaria, 1431 | |
France | |
GHICL hopital ST vincent de Paul | |
Lille, France, 59020 | |
Hôpital de Gui de Chauliac | |
Montpellier, France, 34295 | |
Germany | |
Universitätsklinikum Gießen und Marburg | |
Marburg, Germany, D-35033 | |
Greece | |
Rehibilitation Center "KENTAVROS" | |
Volos, Greece, 382 21 | |
Poland | |
KO-MED Centra Kliniczne Lublin II | |
Lublin, Poland, 20-362 | |
Romania | |
Centrul Medical Clubul Sănătăţii | |
Campulung, Romania, 115100 | |
Spain | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08041 |
Principal Investigator: | Patrick Vermersch, MD, PhD | Hôpital Salengro, Lille, France |
Responsible Party: | AB Science |
ClinicalTrials.gov Identifier: | NCT01433497 |
Other Study ID Numbers: |
AB07002 |
First Posted: | September 14, 2011 Key Record Dates |
Last Update Posted: | April 8, 2020 |
Last Verified: | April 2020 |
multiple sclerosis primary progressive relapse-free secondary progressive |
Neoplasm Metastasis Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Recurrence Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Neoplastic Processes Neoplasms Disease Attributes |