Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01450488

Enrollment

Registered

2011-10-12

Start date

2005-06-30

Completion date

2010-01-31

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

primary progressive multiple sclerosis, relapse-free secondary progressive multiple sclerosis

Brief 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.

Interventions

DRUGmasitinib

masitinib 3 mg/kg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. 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. 2. Patients with EDSS score in the range of 2 to 6.5, inclusive 3. EDSS progression ≥ 1 point within 2 years before inclusion

Exclusion criteria

1. Disease other than MS responsible for clinical signs and/or MRI lesions 2. Secondary progressive MS with relapse in the 2 years before inclusion 3. Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation 4. Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation. 5. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Design outcomes

Primary

Measure	Time frame	Description
change in MSFC	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

Secondary

Measure	Time frame	Description
MSFC subcategories	12 months	timed 25-foot walk (T25FW)
Expanded Disability Status Scale (EDSS)	12 months	—
MFSC subcategories	12 months	9-Hole Peg Test (9-HPT)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026