CompletedPhase 2Progressive MSNCT01450488

What it found

Missed its main goal

The main measure did not show a significant benefit.

“This positive, albeit non-statistically significant response was observed as early as month-3 and sustained through to month-18, with similar trends seen in the PPMS and rfSPMS subpopulations.”
Read by software from the paper's abstract

change relative to baseline in the multiple sclerosis functional composite score (MSFC) · month-12

GroupnValue
masitinib27+103% ± 189 at month-12
placebo8-60% ± 190 at month-12

Read by software from the paper's abstract

What was tested

Treatment tested

  • Masitinib

    Fibroblast growth factor receptor 3 inhibitor|Platelet-derived growth factor receptor inhibitor|Stem cell growth factor receptor inhibitor

What it measured

Main measures

  • change in MSFC

    12 months

    Disability progression

Other measures (3)

  • MSFC subcategories

    12 months

    Disability progressionWalking and mobility
  • Expanded Disability Status Scale (EDSS)

    12 months

    Disability progression
  • MFSC subcategories

    12 months

    Disability progressionThinking and memory

Who could take part

Progressive MS · 18 to 60

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Jun 2005

    2. Main results due

      Jul 2007

    3. Finished

      Jan 2010

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