A 24 week, MRI based, double-blind, randomised, placebo-controlled, mo
A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis.
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- BIRT 2584 XX
What it measured
Main measures
Cumulative number of newly active unique lesions on MRI scans from week 4 to 24 inclusive. Newly active unique lesions result from combining;
MRI lesions
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: 1. Male or female patients aged 18-55 years. Exclusion: 1. Clinically significant disease or medical condition other than MS or MS-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the dose dependent effect BIRT 2584 XX tablets (100 mg, 300 mg, or 500 mg) administered orally once daily (compared to placebo tablets) for the treatment of patients with relapsing forms of Multiple Sclerosis.
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History
Started
Jul 2006