Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND

• Conditions: Multiple Sclerosis Relapsing Remitting; MedDRA version: 9.1Level: LLTClassification code 10063399

• Registration Number: EUCTR2008-006786-92-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Males and females aged 18 to 55 years (inclusive). 2. Women of childbearing potential must:? Have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.? Agree to use two methods of contraception from the screening visit until 8 weeks after study drug discontinuation.3. Presenting with a diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS). 4. Ambulatory and with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5 (inclusive). 5. With at least one of the following characteristics of RRMS:? One or more documented relapse(s) within 12 months prior to the screening visit,? Two or more documented relapses within 24 months prior to the screening visit,? At least one gadolinium-enhancing lesion detected on T1-weighted MRI at the Screening visit (based on central reading).6. In a stable clinical condition:? Without a clinical exacerbation of MS for at least 30 days prior to randomization. 7. Patients who are not responsive to or who do not tolerate treatment of proven efficacy, or who refuse the treatment with disease modifying drugs approved for RRMS, for whatever reason, after they have been informed by the investigator about their respective benefits and possible adverse events.
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

1. Breast feeding women.2. A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.3. Treatment with Within 30 days prior to randomization:? Systemic corticosteroids or adrenocorticotropic hormone (ACTH)? Treatment with &#946;-blockers, diltiazem, verapamil, or digoxin, for any indication? Vaccination, except live vaccines (see below)Within 3 months prior to randomization:? Interferon or glatiramer acetate? Systemic immunosuppressive treatment (e.g., cyclosporine, sirolimus, mycophenolic acid)? Vaccination with live vaccines? Plasma exchange (plasmapheresis, cytapheresis)? Treatment with an investigational drug (within 3 months or 5 half-lives of the drug, whichever is longer), except biological agents (see below)Within 6 months prior to randomization:? Azathioprine or methotrexate? Natalizumab (or previous failure to natalizumab)? Intravenous immunoglobulin? Non-lymphocyte-depleting biologic agents (e.g., daclizumab)At any time prior to randomization:? Cyclophosphamide, mitoxantrone, or cladribine? Lymphocyte-depleting biologic agents such as alemtuzumab or rituximab4. Patient currently treated for an autoimmune disorder other than MS.5. Contraindications for MRI 6. Ongoing bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests.7. Congenital or acquired severe immunodeficiency or known human immunodeficiency virus (HIV) infection.8. Negative antibody test for varicella-zoster virus at screening.9. History or presence of malignancy (except for surgically excised basal or squamous cell skin lesions), lymphoproliferative disease, or history of total lymphoid irradiation or bone marrow transplantation.10. Poorly controlled type I or type II diabetes. 11. Macular edema or diabetic retinopathy (as confirmed within 30 days prior to randomization). 13. Any of the following cardiovascular conditions: ? Resting heart rate (HR) < 55 bpm, as measured by the pre-randomization ECG on Visit 3 (Day 1).? Myocardial infarction within the 6 months prior to randomization or symptomatic ischemic heart disease.? History of or current valvular heart disease.? History of or current heart failure (NYHA Class III or IV).? History or presence of rhythm disorders (e.g., sino atrial heart block, sick sinus syndrome, second or third-degree atrioventricular (AV) block, symptomatic bradycardia, atrial flutter or atrial fibrillation) or ongoing anti-arrhythmic therapy.? History of syncope.? Uncontrolled arterial hypertension.14. Any of the following pulmonary conditions: ? Moderate or severe bronchial asthma or chronic obstructive pulmonary disease (COPD) stage IIIV, i.e., forced expiratory volume in 1 second (FEV1) < 70% of forced vital capacity (FVC), i.e., FEV1/FVC ratio < 0.7.? History of pulmonary fibrosis (scarring of the lung), pulmonary Langerhanscell histiocytosis.? History of tuberculosis, chest X-ray findings at screening or within the previous 3 months, suggestive of active or latent tuberculosis.15. Abnormal liver function tests as defined by elevations of ALT/SGPT or AST/SGOT > 2-fold the upper limit of the normal range (ULN) or total bilirubin > 1.5-fold ULN.16. Any of the following abnormal laboratory values: ? White blood cell (WBC) count < 3,500/mL? Hemoglobin (Hb) < 10 g/dL? Lymphocyte count < 1,000/mL? Platelets < 100,000/mL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified