Multiple SclerosisPhase 2NCT00104143
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
A Phase 2 study testing A4I Antagonist in people with Multiple Sclerosis, run by Hoffmann-La Roche at 39 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- A4I Antagonist
- How many people
- 0 participants
- Where
- 39 sitesin 9 countries
- Study dates
- Oct 2007to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
Canada5 sites
Study site
Edmonton, Alberta, T6G 2G3
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Hull, Quebec, J8Y 1W7
Study site
London, Ontario, N6A 5A5
Study site
Vancouver, British Columbia, V6T 2B5
Poland5 sites
Study site
Gdansk, 80-952
Study site
Lodz, 90-153
Study site
Lublin, 20-954
Study site
Szczecin, 71-242
Study site
Warsaw, 02-957
Russia5 sites
Study site
Moscow, 117997
Study site
Moscow, 123367
Study site
Nizhny Novgorod, 603076
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 197089
Spain5 sites
Study site
Barcelona, 08035
Study site
Barcelona, 08907
Study site
Madrid, 28040
Study site
Málaga, 29010
Study site
Seville, 41071
Bulgaria4 sites
Study site
Sofia, 1113
Study site
Sofia, 1309
Study site
Sofia, 1527
Study site
Sofia, 1606
Germany4 sites
Study site
Marburg, 35033
Study site
Regensburg, 93053
Study site
Tübingen, 72076
Study site
Ulm, 89081
Slovakia4 sites
Study site
Banská Bystrica, 975 17
Study site
Bratislava, 813 69
Study site
Košice, 041 66
Study site
Nitra, 949 01
United Kingdom4 sites
Study site
Liverpool, L9 1AE
Study site
Newcastle upon Tyne, NE1 4LP
Study site
Nottingham, NG7 2UH
Study site
Sheffield, S10 2JF
Czechia3 sites
Study site
Hradec Králové, 500 05
Study site
Ostrava
Study site
Prague, 845 15
About this study
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.
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.
- Conditions
- Multiple Sclerosis
- Being tested
- A4I Antagonist
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A4I AntagonistDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2005 (estimated)
- Study startOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104143
- Sponsor's protocol ID
- NN18344
- Status last verified
- Aug 2016
- First submitted
- 23 Feb 2005
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00104143
- Acronym / sponsor ID
- NN18344
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- First posted
- 24 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A4I Antagonist | Drug | – |
Primary outcome
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A4I Antagonist in people with Multiple Sclerosis, run by Hoffmann-La Roche at 39 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Canada, Poland, Russia, Spain, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.