A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
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.
1 other identifier
interventional
N/A
9 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
39 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2005
CompletedFirst Posted
Study publicly available on registry
February 24, 2005
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedAugust 24, 2016
August 1, 2016
February 23, 2005
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Sofia, 1113, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1606, Bulgaria
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Edmonton, Alberta, T6G 2G3, Canada
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Vancouver, British Columbia, V6T 2B5, Canada
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London, Ontario, N6A 5A5, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Hull, Quebec, J8Y 1W7, Canada
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Hradec Králové, 500 05, Czechia
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Ostrava, Czechia
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Prague, 845 15, Czechia
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Marburg, 35033, Germany
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Regensburg, 93053, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Gdansk, 80-952, Poland
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Lodz, 90-153, Poland
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Lublin, 20-954, Poland
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Szczecin, 71-242, Poland
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Warsaw, 02-957, Poland
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Moscow, 117997, Russia
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Moscow, 123367, Russia
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Nizhny Novgorod, 603076, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 197089, Russia
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 813 69, Slovakia
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Košice, 041 66, Slovakia
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Nitra, 949 01, Slovakia
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Barcelona, 08035, Spain
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Barcelona, 08907, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Seville, 41071, Spain
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Liverpool, L9 1AE, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
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Sheffield, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 23, 2005
First Posted
February 24, 2005
Study Start
October 1, 2007
Last Updated
August 24, 2016
Record last verified: 2016-08