Multiple SclerosisPhase 2NCT01450488
Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
A Phase 2 study testing masitinib in people with Multiple Sclerosis, run by AB Science.
Trial summary
The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- masitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jan 2010
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
- Patients with EDSS score in the range of 2 to 6.5, inclusive
- EDSS progression ≥ 1 point within 2 years before inclusion
Who cannot join
- Disease other than MS responsible for clinical signs and/or MRI lesions
- Secondary progressive MS with relapse in the 2 years before inclusion
- Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
- Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
- Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis
The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- masitinib
- Keywords
- primary progressive multiple sclerosis, relapse-free secondary progressive multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
masitinibDrug
masitinib 3 mg/kg/day
masitinibDrug
masitinib 6 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| masitinib 3 mg/kg/day | Experimental | Not described Receives: Drug: masitinib |
| masitinib 6 mg/kg/day | Experimental | Not described Receives: Drug: masitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in MSFC
average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a > 100% improvement (increase) from baseline
Measured: 12 months
Secondary outcomes (4)
MSFC subcategories
timed 25-foot walk (T25FW)
Measured: 12 months
Expanded Disability Status Scale (EDSS)
Measured: 12 months
MFSC subcategories
9-Hole Peg Test (9-HPT)
Measured: 12 months
MFSC subcategories
Paced Auditory Addition Test (PASAT-3'')
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJun 2005
- Primary completionJul 2007
- Study completionJan 2010
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 SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450488
- Sponsor's protocol ID
- AB04011
- Status last verified
- Dec 2018
- First submitted
- 6 Oct 2011
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.
PubMed 22691628
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01450488
- Acronym / sponsor ID
- AB04011
- Conditions
- Multiple Sclerosis
- Keywords
- primary progressive multiple sclerosis, relapse-free secondary progressive multiple sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Oct 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 evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or 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
- 2
| Arm | Type | Receives |
|---|---|---|
| masitinib 3 mg/kg/day | Experimental | Drug: masitinib |
| masitinib 6 mg/kg/day | Experimental | Drug: masitinib |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
- Patients with EDSS score in the range of 2 to 6.5, inclusive
- EDSS progression ≥ 1 point within 2 years before inclusion
Key exclusion criteria (5 listed)
- Disease other than MS responsible for clinical signs and/or MRI lesions
- Secondary progressive MS with relapse in the 2 years before inclusion
- Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
- Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
- Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
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 |
|---|---|---|
| masitinibmasitinib 3 mg/kg/day | Drug | masitinib 3 mg/kg/day |
| masitinibmasitinib 6 mg/kg/day | Drug | masitinib 6 mg/kg/day |
Primary outcome
change in MSFC
Time frame: 12 months
average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a > 100% improvement (increase) from baseline
4 secondary outcomes
MSFC subcategories
Time frame: 12 months
Expanded Disability Status Scale (EDSS)
Time frame: 12 months
MFSC subcategories
Time frame: 12 months
MFSC subcategories
Time frame: 12 months
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 11 Dec 2018.
- Results publication: PubMed 22691628Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.
- Link to articleLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing masitinib in people with Multiple Sclerosis, run by AB Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change in MSFC (time frame: 12 months). 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 NCT01450488, 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 11 Dec 2018.