Back to resultsA Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
Primary Purpose
Multiple Sclerosis
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
A4I Antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00104143
Brief Title
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
A4I Antagonist
Primary Outcome Measure Information:
Title
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Hull
State/Province
Quebec
ZIP/Postal Code
J8Y 1W7
Country
Canada
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Ostrava
Country
Czech Republic
City
Praha
ZIP/Postal Code
845 15
Country
Czech Republic
City
Marburg
ZIP/Postal Code
35033
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
ULM
ZIP/Postal Code
89081
Country
Germany
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
City
Szczecin
ZIP/Postal Code
71-242
Country
Poland
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
City
Kosice
ZIP/Postal Code
041 66
Country
Slovakia
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
City
Liverpool
ZIP/Postal Code
L9 1AE
Country
United Kingdom
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
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