NCT01433497

Brief Summary

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
656

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_3

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

8.1 years

First QC Date

September 12, 2011

Last Update Submit

April 3, 2020

Conditions

Multiple Sclerosis, Secondary ProgressiveMultiple Sclerosis, Primary ProgressiveMultiple Sclerosis, Relapse Free

Keywords

multiple sclerosisprimary progressiverelapse-freesecondary progressive

Outcome Measures

Primary Outcomes (1)

  • EDSS

    Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

    96 weeks

Secondary Outcomes (2)

  • MSQOL-54

    96 weeks

  • MSFC

    96 weeks

Study Arms (4)

Experimental Arm A

EXPERIMENTAL

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.

Drug: Masitinib

Experimental Arm B

EXPERIMENTAL

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.

Drug: Masitinib

Placebo Comparator A

PLACEBO COMPARATOR

Participants receive placebo given orally twice daily.

Drug: Placebo

Placebo Comparator B

PLACEBO COMPARATOR

Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Drug: Placebo

Interventions

MasitinibDRUG
Also known as: AB1010
Experimental Arm AExperimental Arm B
PlaceboDRUG
Also known as: Placebo Oral Tablet
Placebo Comparator APlacebo Comparator B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \- Patient suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment

Sofia, 1431, Bulgaria

Location

GHICL hopital ST vincent de Paul

Lille, 59020, France

Location

Hôpital de Gui de Chauliac

Montpellier, 34295, France

Location

Universitätsklinikum Gießen und Marburg

Marburg, D-35033, Germany

Location

Rehibilitation Center "KENTAVROS"

Volos, 382 21, Greece

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

Centrul Medical Clubul Sănătăţii

Campulung Muscel, 115100, Romania

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (1)

  • Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

    PMID: 35190477DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic ProgressiveMultiple Sclerosis

Interventions

masitinib

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Vermersch, MD, PhD

    Hôpital Salengro, Lille, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 14, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2019

Study Completion

February 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

RO(1)BU(1)DE(1)PL(1)FR(2)ES(1)GR(1)