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Masitinib in Patients With Primary Progressive Multiple Sclerosis (PPMS) or Relapse-free Secondary Progressive Multiple Sclerosis (SPMS)

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ClinicalTrials.gov Identifier: NCT01450488
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
AB Science

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: masitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: masitinib 3 mg/kg/day Drug: masitinib
masitinib 3 mg/kg/day

Experimental: masitinib 6 mg/kg/day Drug: masitinib
masitinib 6 mg/kg/day




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. MSFC subcategories [ Time Frame: 12 months ]
    timed 25-foot walk (T25FW)

  2. Expanded Disability Status Scale (EDSS) [ Time Frame: 12 months ]
  3. MFSC subcategories [ Time Frame: 12 months ]
    9-Hole Peg Test (9-HPT)

  4. MFSC subcategories [ Time Frame: 12 months ]
    Paced Auditory Addition Test (PASAT-3'')



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01450488     History of Changes
Other Study ID Numbers: AB04011
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by AB Science:
primary progressive multiple sclerosis
relapse-free secondary progressive multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Recurrence
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes