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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450488
• Other study ID #: AB04011
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: January 2010

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2010
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Recurrence
• Sclerosis

Intervention

Drug:
• masitinib
masitinib 3 mg/kg/day
• masitinib
masitinib 6 mg/kg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

References & Publications (1)

Vermersch P, Benrabah R, Schmidt N, Zéphir 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: 10.1186/1471-2377-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	MSFC subcategories	timed 25-foot walk (T25FW)	12 months
Secondary	Expanded Disability Status Scale (EDSS)		12 months
Secondary	MFSC subcategories	9-Hole Peg Test (9-HPT)	12 months
Secondary	MFSC subcategories	Paced Auditory Addition Test (PASAT-3'')	12 months

External Links

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