Extension Study of MT-1303

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:

A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890655
• Other study ID #: MT-1303-E05
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2013
• Last updated: April 8, 2016
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• MT-1303-Low

• MT-1303-Middle

• MT-1303-High

Locations

Country	Name	City	State
Belgium	Research Site	City name
Bulgaria	Research Site	City name
Canada	Research Site	City name
Croatia	Research Site	City name
Czech Republic	Research Site	City name
Finland	Research Site	City name
Germany	Research Site	City name
Hungary	Research Site	City name
Italy	Research Site	City name
Lithuania	Research Site	City name
Poland	Research Site	City name
Russian Federation	Research Site	City name
Serbia	Research Site	City name
Spain	Research Site	City name
Turkey	Research Site	City name
Ukraine	Research Site	City name
United Kingdom	Research Site	City name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Canada,  Croatia,  Czech Republic,  Finland,  Germany,  Hungary,  Italy,  Lithuania,  Poland,  Russian Federation,  Serbia,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments	Adverse Events	Month 18	Yes
Secondary	Clinical efficacy	Annualised relapse rate(ARR)	Month 18	No
Secondary	Magnetic Resonance Imaging (MRI)	Change and percent change in brain volume at EOT	Month 18	No