Relapsing forms of Multiple Sclerosis MedDRA version: 8.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18-55 years. 2. Diagnosis of MS according to the revised McDonald criteria (R06-0788). 3. Score of 0 5.5 on the Kurtzke EDSS at screening. 4. Screening MRI must show at least three lesions on the T2 scan with a size of at least 3 mm (to be determined by Investigator and confirmed by the Central MRI evaluation). 5. At least one clearly identified documented relapse, subsequent to diagnosis, within 12 months prior to screening, and disease duration from onset of relapse > 6 months or two documented relapses in the last 24 months or one documented relapse between 12 and 24 months before screening if there is > 1 documented enhancing lesion in a brain-spinal cord MRI performed within 2 months prior to screening. 6. Clinically stable, and without relapse within 30 days of Visit 1. If a patient should experience a relapse between Visit 1 and Visit 2, they can be re-screened for inclusion in the trial once only. 7. The patient or the patient’s legally acceptable representative must be able to give informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation. 8. Subject must be willing and able to comply with the protocol requirements for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. 2. Patients with non-relapsing, progressive MS. 3. Patients with conditions that could interfere with the MRI or any other evaluation in this trial. 4. Patients with a known allergy to gadolinium containing contrast agents 5. Patients who have received methylprednisolone and or oral prednisone in the four weeks prior to Visit 1. 6. Patients who have received Tysabri® (nataluzimab) or have received treatment with any VLA-4 antagonist at any time. 7. Patients who are receiving, or who have received monoclonal antibodies within six months prior to Visit 1. 8. Patients who are receiving, or who have received mitoxantrone or cladribine within 1 year prior to Visit 1. 9. Patients who are receiving, or who have received beta-interferons, azathioprine, cyclophosphamide, methotrexate or copaxone within three months prior to Visit 1. 10. Patients who have received total lymphoid irradiation at any time. 11. Patients using treatments that could interfere with the primary endpoint of the trial. 12. Patients on treatment with warfarin, paracetamol (acetaminophen), some non-steroidal anti-inflammatory drugs (NSAIDs), some antidepressants, medications known to induce or inhibit CYP3A/4, or any other concomitant medication where potential drug-drug interactions with BIRT 2584 XX could either result in decreased efficacy or an unacceptable benefit-risk assessment, and where replacement of that concomitant medication with a safe equivalent drug is not possible. 13. Patients with active liver disease or history of any significant liver disease. 14. Patients with serum creatinine and/or WBC count > 1.5 x ULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient). 15. Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening. (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient). 16. Patients with abnormal values of other laboratory parameters that would define a clinically significant disease as described in # 1 above. 17. Patients with a history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (or who have a positive test at screening ), or any serious infection (requiring hospitalisation or parenteral antibiotic therapy) in the past 3 months prior to screening. 18. Patients with a history of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma. 19. Patients with the following findings at the screening visit that could interfere with cardiac repolarisation : • marked baseline prolongation of QT/QTC interval as measured on ECG (e.g. QTC interval > 450ms); • history of additional risk factors for Torsade de pointe (e.g. heart failure, - hypokalemia, family history of long QT syndrome); • use of concomitant medications that prolong the QT/QTC interval. 20. Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion is to exclude patients who are considered to be at risk of not complying with or abusing the tria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: To characterise the PK of BIRT 2584 XX tablets (100 mg, 300 mg, or 500 mg) in patients with relapsing forms of Multiple Sclerosis in an exploratory fashion. ;Primary end point(s): Cumulative number of newly active unique lesions on MRI scans from week 4 to 24 inclusive. Newly active unique lesions result from combining; Newly enhancing lesions on T1-weighted contrast enhanced scans and New and newly enlarging lesions on proton density/T2-weighted scans, but non-enhancing on T1-weighted scans | — |
Countries
Czech Republic, Netherlands
Outcome results
None listed