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Last updated: 28 Jul 2015

Masitinib

Summary
Trade name: 
N/A
Class: 
Immunomodulator
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Target: 
KIT (a stem cell factor, also called c-KIT) receptor as well as select other tyrosine kinases
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Mast cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Status for MS: 
Phase III
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
(8)
AB Science announces recruitment of first patient in phase 3 study of masitinib in progressive multiple sclerosis
Businesswire.com, 6 Sep 2011
Accessed on 22 Feb 2012 from http://www.businesswire.com/news/home/20110906006398/en/AB-Science-announces-recruitment-patient-phase-3.
Administration: 
Oral
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Commercial: 
Under development by AB Science
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Trials in a variety of non-life-threatening conditions, including MS, have been halted by French regulators because of the risk of adverse events that might be fatal (2012)
(20)
France Banned AB Science Drug Studies Because of Side Effects
Bloomberg Business, 8 Jul 2015
Accessed on 14 Jul 2015 from http://www.bloomberg.com/news/articles/2015-07-08/france-banned-ab-science-drug-studies-because-of-side-effects.
Names
Name: 
Masitinib
Trade name: 
N/A
Synonyms: 
4-((4-Methylpiperazin-1-yl)methyl)-N-(4-methyl-3-((4-(pyridin-3-yl)-1,3-thiazol-2-yl)amino)phenyl)benzamide
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
AB 1010
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
AB-1010
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
AB1010
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Masitinib
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
UNII-M59NC4E26P
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Systematic name: 
4-((4-Methylpiperazin-1-yl)methyl)-N-(4-methyl-3-((4-(pyridin-3-yl)-1,3-thiazol-2-yl)amino)phenyl)benzamide
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Physiology
Class: 
Immunomodulator
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Target: 
KIT (a stem cell factor, also called c-KIT) receptor as well as select other tyrosine kinases
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Mast cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Properties: 
Toxicity and pharmacokinetics have been studied in dogs
(4)
Masitinib mesylate application for conditional approval
Food and Drug Administration, 15 Dec 2010
Accessed on 22 Feb 2012 from http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM245243.pdf.
(5)
Scientific discussion for the approval of Masivet
European Medicines Agency, Nov 2008
Accessed on 22 Feb 2012 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/veterinary/000128/WC500064714.pdf.
Specificity compared to other tyrosine kinase inhibitors (such as imatinib) may improve safety profile
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract

Mechanisms/Effects

Human: 
Blocks the stem cell factor receptor KIT (also called the c-KIT receptor) in cultured cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Blocks platelet derived growth factor receptor in cultured cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Does not target kinases thought to be involved in cardiotoxicity such as ABL, based on experiments in cultured cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Inhibits human mast cell degranulation, cytokine production, and migration of bone marrow cells in cultured cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Slowed cognitive decline in Alzheimer disease in a Phase II study, presumably by acting on mast cells in the brain
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
Likely regulates inflammation indirectly, via mast cells’ release of proinflammatory mediators and control of blood-brain barrier permeability
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
Improved symptoms of rheumatoid arthritis in a Phase II study
(7)
Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study.
Tebib J, Mariette X, Bourgeois P, Flipo R-M, Gaudin P, Le Loët X, Gineste P, Guy L, Mansfield CD, Moussy A, et al.
Arthritis Res Ther. 2009; 11(3):R95. Epub 2009 Jun 23. PMID: 19549290. Abstract
Animal: 
Inhibits tumor growth in vivo in mice
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Reduces brain ischemia caused by experimental stroke in rats
(19)
Neuroprotective effect of masitinib in rats with postischemic stroke.
Kocic I, Kowianski P, Rusiecka I, Lietzau G, Mansfield C, Moussy A, Hermine O, Dubreuil P
Naunyn Schmiedebergs Arch Pharmacol. 2014 Oct 26. Epub 2014 Oct 26. PMID: 25344204. Abstract
Does not damage chromosomes or affect mitosis in mouse cells
(3)
Masitinib (AB1010), a potent and selective tyrosine kinase inhibitor targeting KIT.
Dubreuil P, Letard S, Ciufolini M, Gros L, Humbert M, Castéran N, Borge L, Hajem B, Lermet A, Sippl W, et al.
PLoS One. 2009; 4(9):e7258. Epub 2009 Sep 30. PMID: 19789626. Abstract
Regulatory and Commercial Status
Status for MS: 
Phase III
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
(8)
AB Science announces recruitment of first patient in phase 3 study of masitinib in progressive multiple sclerosis
Businesswire.com, 6 Sep 2011
Accessed on 22 Feb 2012 from http://www.businesswire.com/news/home/20110906006398/en/AB-Science-announces-recruitment-patient-phase-3.
Highest status achieved (for any condition): 
Marketing Authorization Application for the treatment of pancreatic cancer has been filed with the European Medicines Agency (16 October 2012)
(14)
AB Science confirms the filing for the Marketing Authorization Application to the European Medicines Agency of masitinib in the treatment of pancreatic cancer
AB Science, 16 Oct 2012
Accessed on 1 Nov 2012 from http://www.ab-science.com/file_bdd/1350403049_absciencepancreasemafilingvdefven.pdf.
Marketing Authorization Application for the conditional approval in the treatment of pancreatic cancer has been accepted by the European Medicines Agency (30 October 2012)
(15)
European Medicines Agency accepts Marketing Authorization Application for conditional approval of masitinib in the treatment of pancreatic cancer
AB Science, 30 Oct 2012
Accessed on 1 Nov 2012 from http://www.ab-science.com/file_bdd/1351622639_abscienceresultph3pancreasvdefuk.pdf.
Other uses: 
Canine mast cell tumors (registered for veterinary use in US and UK)
(12)
“Veterinary Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Phase III trial for use in Alzheimer's disease has been launched (20 May 2013)
(16)
Launch of a phase 3 clinical trial in the treatment of Alzheimer’s disease with masitinib
AB Science, 20 May 2013
Accessed on 21 May 2013 from http://www.ab-science.com/file_bdd/1369064860_absciencepressreleasephase3alzenfinal.pdf.
Phase III trial for use in amyotrophic lateral sclerosis has begun (2013)
(17)
Masitinib is being investigated in the treatment of amyotrophic lateral sclerosis (ALS)
The Wall Street Journal, 4 Nov 2013
Accessed on 6 Nov 2013 from http://online.wsj.com/article/PR-CO-20131104-908831.html?dsk=y.
Asthma (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Gastrointestinal stromal tumors (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
May have neuroprotective effects after ischemic stroke, based on a study in rats
(19)
Neuroprotective effect of masitinib in rats with postischemic stroke.
Kocic I, Kowianski P, Rusiecka I, Lietzau G, Mansfield C, Moussy A, Hermine O, Dubreuil P
Naunyn Schmiedebergs Arch Pharmacol. 2014 Oct 26. Epub 2014 Oct 26. PMID: 25344204. Abstract
Mastocytosis (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Metastatic solid tumors (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Multiple myeloma (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Pancreatic cancer (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Rheumatoid arthritis (investigational)
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Administration: 
Oral
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Negative effects: 
Abdominal pain
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Anemia[ [1337]]
Asthenia
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Diarrhea
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Edema
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Nausea
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Neutropenia
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Rash
(6)
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet J-P, et al.
Alzheimers Res Ther. 2011; 3(2):16. Epub 2011 Apr 19. PMID: 21504563. Abstract
(11)
Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST).
Le Cesne A, Blay J-Y, Bui B N, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, et al.
Eur J Cancer. 2010 May; 46(8):1344-51. Epub 2010 Mar 06. PMID: 20211560. Abstract
Commercial: 
Under development by AB Science
(2)
“Human Medicines” page
AB Science website
Accessed on 22 Feb 2012 from http://www.ab-science.com/.
Trials in a variety of non-life-threatening conditions, including MS, have been halted by French regulators because of the risk of adverse events that might be fatal (2012)
(20)
France Banned AB Science Drug Studies Because of Side Effects
Bloomberg Business, 8 Jul 2015
Accessed on 14 Jul 2015 from http://www.bloomberg.com/news/articles/2015-07-08/france-banned-ab-science-drug-studies-because-of-side-effects.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
(9)
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
ClinicalTrials.gov, 13 Sep 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/study/NCT01433497.
Phase: 
Phase III trial
(8)
AB Science announces recruitment of first patient in phase 3 study of masitinib in progressive multiple sclerosis
Businesswire.com, 6 Sep 2011
Accessed on 22 Feb 2012 from http://www.businesswire.com/news/home/20110906006398/en/AB-Science-announces-recruitment-patient-phase-3.
(9)
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
ClinicalTrials.gov, 13 Sep 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/study/NCT01433497.
Study Design: 
Company-sponsored, prospective, multicenter, randomized, double-blind, placebo-controlled trial to examine the safety and efficacy of masitinib (6 mg per kg per day), as judged by changes in the MS functional composite score (primary outcome)
(9)
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
ClinicalTrials.gov, 13 Sep 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/study/NCT01433497.
(21)
AB Science announces successful non futility test for masitinib in progressive forms of multiple sclerosis
AB Science, 23 Jul 2015
Accessed on 28 Jul 2015 from http://www.ab-science.com/file_bdd/content/1437673621_PositivefutilitytestforMS_vEN.pdf.
Disease Stage: 
PPMS or relapse-free SPMS
(8)
AB Science announces recruitment of first patient in phase 3 study of masitinib in progressive multiple sclerosis
Businesswire.com, 6 Sep 2011
Accessed on 22 Feb 2012 from http://www.businesswire.com/news/home/20110906006398/en/AB-Science-announces-recruitment-patient-phase-3.
(9)
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
ClinicalTrials.gov, 13 Sep 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/study/NCT01433497.
(21)
AB Science announces successful non futility test for masitinib in progressive forms of multiple sclerosis
AB Science, 23 Jul 2015
Accessed on 28 Jul 2015 from http://www.ab-science.com/file_bdd/content/1437673621_PositivefutilitytestforMS_vEN.pdf.
Enrollment/Number of Patients: 
600
(21)
AB Science announces successful non futility test for masitinib in progressive forms of multiple sclerosis
AB Science, 23 Jul 2015
Accessed on 28 Jul 2015 from http://www.ab-science.com/file_bdd/content/1437673621_PositivefutilitytestforMS_vEN.pdf.
Duration: 
96 weeks
(8)
AB Science announces recruitment of first patient in phase 3 study of masitinib in progressive multiple sclerosis
Businesswire.com, 6 Sep 2011
Accessed on 22 Feb 2012 from http://www.businesswire.com/news/home/20110906006398/en/AB-Science-announces-recruitment-patient-phase-3.
(9)
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
ClinicalTrials.gov, 13 Sep 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/study/NCT01433497.
(21)
AB Science announces successful non futility test for masitinib in progressive forms of multiple sclerosis
AB Science, 23 Jul 2015
Accessed on 28 Jul 2015 from http://www.ab-science.com/file_bdd/content/1437673621_PositivefutilitytestforMS_vEN.pdf.
Status/Outcome: 
Results expected after December 2014
(9)
Masitinib in Patients with Progressive or Relapse-Free Secondary Multiple Sclerosis
ClinicalTrials.gov, 13 Sep 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/study/NCT01433497.
; Data Safety Monitoring Board has recommended continuation of the trial because safety concerns have not been observed (6 October 2014)
(18)
BRIEF-AB Science says DSMB recommends continuation of phase 3 masitinib study
Reuters, 6 Oct 2014
Accessed on 14 Oct 2014 from http://www.reuters.com/article/2014/10/06/absciencesa-brief-idUSFWN0S100120141006.
; Independent Data Safety Monitoring Committee recommends trial continuation because of a successful non futility analysis (i.e., indicating that the study is not futile) (23 July 2015)
(21)
AB Science announces successful non futility test for masitinib in progressive forms of multiple sclerosis
AB Science, 23 Jul 2015
Accessed on 28 Jul 2015 from http://www.ab-science.com/file_bdd/content/1437673621_PositivefutilitytestforMS_vEN.pdf.
Trial name: 
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS) (publ June, 2012)
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Phase: 
Phase II trial
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Study Design: 
Company-sponsored, randomized, placebo-controlled trial to test the safety and efficacy of two doses of masitinib (3 or 6 mg per kg per day), as measured by changes in the MS functional composite score (primary outcome)
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Disease Stage: 
PPMS or SPMS
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Enrollment/Number of Patients: 
35
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Duration: 
12 months
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Status/Outcome: 
A clinical response to treatment was reported in some participants, but the response was not statistically significant; masitinib was also associated with a higher incidence of severe adverse events than was placebo
(10)
Masitinib in Patients with Primary Progressive Multiple Sclerosis (PPMS) or Relapse-Free Secondary Multiple Sclerosis (SPMS)
ClinicalTrials.gov, 10 Oct 2011
Accessed on 22 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01450488.
(13)
Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study.
Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O
BMC Neurol. 2012 Jun 12; 12(1):36. PMID: 22691628. Abstract
Head-to-Head Trials: 
Other Trials: 
References
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.

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DOI: 
doi/10.7493/msdf.10.1385.1