Relapsing-remitting Multiple Sclerosis MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ONO-4641/MSC2430913A
Product Code: ONO-4641/MSC2430913A
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ONO-4641/MSC2430913A
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Merck Serono S.A. - Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible to participate in this study if they meet all of the following criteria: 1. Completed 26 weeks of double-blind phase of Study ONO-4641POU006 2. For females: a. Patients of childbearing potential who agree to use an acceptable form of birth control (i.e. double barrier method; diaphragm plus condom, intrauterine device plus condom, hormonal contraception plus condom, spermicidal gel plus condom, or abstinence) throughout the study and until 2 months after the last dose; b. Negative serum and urine human chorionic gonadotropin (hCG) assay at Visit 9; 3. For males: a. Agree to use a condom with spermicide when engaging in sexual intercourse during participation in the study and until 2 months after the last dose; b. Agree to refrain from sperm donation during participation in the study and until 2 months after the last dose; 4. Able and willing to provide signed, written, Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 376 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Patients will not be eligible to participate in this study if any of the following criteria apply: 1. Presence of any dermatological abnormalities during Study ONO-4641POU006 that in the opinion of the investigator or the Sponsor (Ono Pharmaceutical Co., Ltd.) could increase the risk of the patient developing a skin cancer; 2. In the opinion of the Investigator, a patient who may not be able to cooperate fully with the study staff, may have difficulty in some study requirements, or is otherwise not qualified for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this 122-week active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis (RRMS) in patients who have completed an initial 26-week study (ONO-4641POU006).;Secondary Objective: N/A;Primary end point(s): The number of Gd-enhanced lesions, lesion volume, and brain volume obtained by MRI at Weeks 40, 52, 100, and 148 will be compared with that of the baseline of the Extension Study ;Timepoint(s) of evaluation of this end point: Weeks 0, 40, 52, 100, and 148 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium, Canada, Czech Republic, Germany, Greece, Japan, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed