Multiple Sclerosis, Secondary ProgressivePhase 3NCT01433497
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
A Phase 3 study testing Masitinib in people with Multiple Sclerosis, Secondary Progressive and Multiple Sclerosis, Primary Progressive, run by AB Science at 8 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free
- What is being tested?
- Masitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 656 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Aug 2011to Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
France2 sites
GHICL hopital ST vincent de Paul
Lille, 59020
Hôpital de Gui de Chauliac
Montpellier, 34295
Bulgaria1 site
"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
Sofia, 1431
About this study
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
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.
Read the detailed description
Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes. The objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after 3 months of treatment versus matched placebo, in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1 design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96 weeks of treatment in the overall study population with subgroup analysis performed in stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).
- Conditions
- Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free
- Being tested
- Masitinib, Placebo
- Keywords
- multiple sclerosis, primary progressive, relapse-free, secondary progressive
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasitinibDrug
Also called AB1010
PlaceboDrug
Also called Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A | Experimental | Participants receive masitinib (4.5 mg/kg/day), given orally twice daily. Receives: 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. Receives: Drug: Masitinib |
| Placebo Comparator A | Placebo comparator | Participants receive placebo given orally twice daily. Receives: Drug: Placebo |
| Placebo Comparator B | Placebo comparator | Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDSS
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment
Measured: 96 weeks
Secondary outcomes (2)
MSQOL-54
Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
Measured: 96 weeks
MSFC
Multiple Sclerosis Functional Composite (MSFC)
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Secondary ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Vermersch, MD, PhD, Principal investigator, Hôpital Salengro, Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433497
- Sponsor's protocol ID
- AB07002
- Status last verified
- Apr 2020
- First submitted
- 12 Sep 2011
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35190477
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01433497
- Acronym / sponsor ID
- AB07002
- Conditions
- Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free
- Keywords
- multiple sclerosis, primary progressive, relapse-free, secondary progressive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 656 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes. The objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after 3 months of treatment versus matched placebo, in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1 design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96 weeks of treatment in the overall study population with subgroup analysis performed in stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A | Experimental | Drug: MasitinibParticipants receive masitinib (4.5 mg/kg/day), given orally twice daily. |
| Experimental Arm B | Experimental | Drug: MasitinibParticipants 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. |
| Placebo Comparator A | Placebo comparator | Drug: PlaceboParticipants receive placebo given orally twice daily. |
| Placebo Comparator B | Placebo comparator | Drug: PlaceboParticipants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MasitinibAlso: AB1010 | Drug | Experimental Arm A, Experimental Arm B |
| PlaceboAlso: Placebo Oral Tablet | Drug | Placebo Comparator A, Placebo Comparator B |
Primary outcome
EDSS
Time frame: 96 weeks
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment
2 secondary outcomes
MSQOL-54
Time frame: 96 weeks
MSFC
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Derived from this study: PubMed 35190477Vermersch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Vermersch, MD, PhD principal investigator
Hôpital Salengro, Lille, France
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib in people with Multiple Sclerosis, Secondary Progressive and Multiple Sclerosis, Primary Progressive, run by AB Science at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Bulgaria, Germany, Greece, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDSS (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01433497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.