Extension Study of MT-1303

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01890655
• Collaborator: (none)
• Enrollment: 367
• Locations: 17
• Arms: 3
• Duration (Months): 31
• Patients Per Site: 21.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis	Drug: MT-1303-Low; Drug: MT-1303-Middle; Drug: MT-1303-High	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 367 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT-1303-Low MT-1303-Low Dose	Drug: MT-1303-Low
Experimental: MT-1303-Middle MT-1303-Middle Dose	Drug: MT-1303-Middle
Experimental: MT-1303-High MT-1303-High Dose	Drug: MT-1303-High

Outcome Measures

Primary Outcome Measures

1. Safety assessments [Month 18]

   Adverse Events

Secondary Outcome Measures

1. Clinical efficacy [Month 18]

   Annualised relapse rate(ARR)

2. Magnetic Resonance Imaging (MRI) [Month 18]

   Change and percent change in brain volume at EOT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	City name		Belgium
2	Research Site	City name		Bulgaria
3	Research Site	City name		Canada
4	Research Site	City name		Croatia
5	Research Site	City name		Czech Republic
6	Research Site	City name		Finland
7	Research Site	City name		Germany
8	Research Site	City name		Hungary
9	Research Site	City name		Italy
10	Research Site	City name		Lithuania
11	Research Site	City name		Poland
12	Research Site	City name		Russian Federation
13	Research Site	City name		Serbia
14	Research Site	City name		Spain
15	Research Site	City name		Turkey
16	Research Site	City name		Ukraine
17	Research Site	City name		United Kingdom

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Ludwig Kappos, MD, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01890655
• Other Study ID Numbers: MT-1303-E05
• First Posted: Jul 2, 2013
• Last Update Posted: Apr 11, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Mitsubishi Tanabe Pharma Corporation: relapsing-remitting multiple sclerosis; RRMS
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis

Study Results

No Results Posted as of Apr 11, 2016