Clinical trial NCT00104143: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
Secondary outcomes:
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
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Hull
country: Canada
state: Quebec
city: Hradec Kralove
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Marburg
country: Germany
city: Regensburg
country: Germany
city: Tübingen
country: Germany
city: ULM
country: Germany
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Nitra
country: Slovakia
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Liverpool
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: