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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01450488
First received: October 6, 2011
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Multiple Sclerosis
 Drug: masitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AB Science:

Primary Outcome Measures:
  • change in MSFC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • MSFC subcategories [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    timed 25-foot walk (T25FW)

  • Expanded Disability Status Scale (EDSS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • MFSC subcategories [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    9-Hole Peg Test (9-HPT)

  • MFSC subcategories [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Paced Auditory Addition Test (PASAT-3'')


Enrollment: 35
Study Start Date: June 2005
Study Completion Date: January 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01450488     History of Changes
Other Study ID Numbers: AB04011
Study First Received: October 6, 2011
Last Updated: October 10, 2011
Health Authority: France: Committee for the Protection of Personnes

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

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

ClinicalTrials.gov processed this record on May 22, 2013