Extension Study of MT-1303

NCT01890655 | Completed Phase 2 DMC

• 1 other identifier: MT-1303-E05
• Study Type: interventional
• Target: 367
• Locations: 17 countries
• Sites: 17

Brief Summary

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

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

relapsing-remitting multiple sclerosis; RRMS

Outcome Measures

Primary Outcomes (1)

• Safety assessments

  Adverse Events

  Month 18

Secondary Outcomes (2)

• Clinical efficacy

  Month 18

• Magnetic Resonance Imaging (MRI)

  Month 18

Study Arms (3)

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

MT-1303-Low DRUG

MT-1303-Low

MT-1303-Middle DRUG

MT-1303-Middle

MT-1303-High DRUG

MT-1303-High

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (17)

Research Site

City Name, Belgium

Location

Research Site

City Name, Bulgaria

Location

Research Site

City Name, Canada

Location

Research Site

City Name, Croatia

Location

Research Site

City Name, Czechia

Location

Research Site

City Name, Finland

Location

Research Site

City Name, Germany

Location

Research Site

City Name, Hungary

Location

Research Site

City Name, Italy

Location

Research Site

City Name, Lithuania

Location

Research Site

City Name, Poland

Location

Research Site

City Name, Russia

Location

Research Site

City Name, Serbia

Location

Research Site

City Name, Spain

Location

Research Site

City Name, Turkey (Türkiye)

Location

Research Site

City Name, Ukraine

Location

Research Site

City Name, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ludwig Kappos, MD

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 2, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

LI (1); FI (1); DE (1); RU (1); CA (1); TU (1); GB (1); SE (1); ES (1); BU (1); CR (1); IT (1); PL (1); HU (1); UA (1); BE (1); CZ (1)