Extension Study of MT-1303 | NCT01890655

Studies
Extension Study of MT-1303

NCT01890655

Sponsor

Tanabe Pharma Corporation

Status

Completed

Last Update Posted

Apr 11, 2016Estimated

Enrollment

367Actual

Phase

Phase 2

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

MT-1303-Low
MT-1303-Middle
MT-1303-High

Countries

Belgium
Bulgaria
Canada
Croatia
Czechia
Finland
Germany
Hungary
Italy
Lithuania
Poland
Russia
Serbia
Spain
Turkey (Türkiye)
Ukraine
United Kingdom

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

Apr 2016

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

Aug 2013

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jul 2, 2013Estimated

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

Apr 8, 2016

Last Update Posted Date

Apr 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).

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

367Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MT-1303-Low	Experimental	MT-1303-Low Dose	Drug: MT-1303-Low
MT-1303-Middle	Experimental	MT-1303-Middle Dose	Drug: MT-1303-Middle
MT-1303-High	Experimental	MT-1303-High Dose	Drug: MT-1303-High

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MT-1303-Low	Drug		MT-1303-Low
MT-1303-Middle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessments	Adverse Events	Month 18

Secondary Outcomes

Measure	Description	Time Frame
Clinical efficacy	Annualised relapse rate(ARR)	Month 18
Magnetic Resonance Imaging (MRI)	Change and percent change in brain volume at EOT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completion of the 24-week treatment period in MT-1303-E04 as per protocol
Able to provide written informed consent and to comply with the requirements of the protocol
For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.

Exclusion Criteria:

Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
Newly diagnosed diabetes mellitus during MT-1303-E04

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ludwig Kappos, MD	University Hospital, Basel, Switzerland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		City Name			Belgium
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided