A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.

August 23, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.

This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1309
      • Sofia, Bulgaria, 1113
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
    • Ontario
      • London, Ontario, Canada, N6A 5A5
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hull, Quebec, Canada, J8Y 1W7
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
      • Ostrava, Czech Republic
      • Praha, Czech Republic, 845 15
  • Germany
      • Marburg, Germany, 35033
      • Regensburg, Germany, 93053
      • Tübingen, Germany, 72076
      • ULM, Germany, 89081
  • Poland
      • Gdansk, Poland, 80-952
      • Lodz, Poland, 90-153
      • Lublin, Poland, 20-954
      • Szczecin, Poland, 71-242
      • Warszawa, Poland, 02-957
  • Russian Federation
      • Moscow, Russian Federation, 123367
      • Moscow, Russian Federation, 117997
      • Nizhny Novgorod, Russian Federation, 603076
      • St Petersburg, Russian Federation, 194044
      • St Petersburg, Russian Federation, 197089
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
      • Bratislava, Slovakia, 813 69
      • Kosice, Slovakia, 041 66
      • Nitra, Slovakia, 949 01
  • Spain
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08907
      • Madrid, Spain, 28040
      • Malaga, Spain, 29010
      • Sevilla, Spain, 41071
  • United Kingdom
      • Liverpool, United Kingdom, L9 1AE
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
      • Nottingham, United Kingdom, NG7 2UH
      • Sheffield, United Kingdom, S10 2JF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-59 years of age;
  • relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria);
  • >=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment;
  • EDSS score of <=6.5;
  • inadequate response to approved treatment(Canada only).

Exclusion Criteria:

  • MS attack within 1 month before enrollment;
  • systemic corticosteroids within 1 month before enrollment;
  • MS treatments (non-symptomatic) within specified periods before enrollment;
  • an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period

Secondary Outcome Measures

Outcome Measure
No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Registration Dates

First Submitted

February 23, 2005

First Submitted That Met QC Criteria

February 23, 2005

First Posted (Estimate)

February 24, 2005

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN18344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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