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

NCT ID: NCT00104143

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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A4I Antagonist

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Hull, Quebec, Canada

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Hradec Králové, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Marburg, , Germany

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Regensburg, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Gdansk, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Nitra, , Slovakia

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Seville, , Spain

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Liverpool, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Nottingham, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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Bulgaria Canada Czechia Germany Poland Russia Slovakia Spain United Kingdom

Other Identifiers

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NN18344

Identifier Type: -

Identifier Source: org_study_id

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