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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00104143

First received: February 23, 2005

Last updated: October 10, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2005

Last Updated Date

October 10, 2007

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00104143 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Drug: A4I Antagonist

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 59 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bulgaria, Canada, Czech Republic, Germany, Poland, Russian Federation, Slovakia, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00104143

Other Study ID Numbers ^ICMJE

NN18344

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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