Masitinib in Primary Progressive Multiple Sclerosis or Re... | NCT01450488

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

NCT01450488

Sponsor

AB Science

Status

Completed

Last Update Posted

Dec 11, 2018Actual

Enrollment

35Actual

Phase

Phase 2

Conditions

Multiple Sclerosis

Interventions

masitinib
masitinib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Jan 2010Actual

First Submitted Date

Oct 6, 2011

First Submission Date that Met QC Criteria

Oct 10, 2011

First Posted Date

Oct 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2018

Last Update Posted Date

Dec 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
masitinib 3 mg/kg/day	Experimental		Drug: masitinib
masitinib 6 mg/kg/day	Experimental		Drug: masitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
masitinib	Drug	masitinib 3 mg/kg/day	masitinib 3 mg/kg/day
masitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
MSFC subcategories	timed 25-foot walk (T25FW)	12 months
Expanded Disability Status Scale (EDSS)		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22691628	Result	Vermersch P, Benrabah R, Schmidt N, Zephir 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: 10.1186/1471-2377-12-36.

ID	Term
D009103	Multiple Sclerosis
D020528	Multiple Sclerosis, Chronic Progressive

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases