A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
- Conditions
- Relapsing-remitting Multiple SclerosisMedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-018705-11-DE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 376
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. From participation and throughout the duration of the study, male and female subjects of childbearing potential (ie, non-sterilized, premenopausal females) who are sexually active must use adequate contraception until 2 months after the last dose of study medication. An acceptable method of contraception is defined as one that has no failure rate or a <1% failure rate. It is recommended to combine a hormonal method (PEARL index < 1) with a barrier method. The following contraception methods are especially reliable according to the guidelines of the German Association of Gynaecology and Obstetrics:
• Oral contraceptive pill with estrogen and gestagen (no micro pill)
• Vaginal ring (i.e.. NuvaRing®)
• Contraception plaster (i.e. EVRA®)
• Estrogen-free ovulation inhibitor (i.e. Cerazette®)
• Intradermal contraception sticks with progesteron (i.e. Implanon®)
• an injection of gestagen every 3 months
• Contraceptive coil with Progesteron (i.e. Minera®)
• Contraception with double barrier method (condom, contraceptive sponge, diaphragm, or vaginal ring with spermicidal gel or foam)
Male subjects and women of child bearing potential will be provided with information on acceptable methods of contraception as part of the subject informed consent process, and will be advised of the requirements for avoidance of pregnancy until 2 months after the last dose of study medication. Subjects will receive continued guidance with respect to the avoidance of pregnancy as part of the study procedures. In addition to a negative serum hCG pregnancy test throughout the study period, subjects also must have a negative urine hCG pregnancy test on the day of the first dose of study medication, prior to receiving the first dose of the extension study drug.
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
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.
3. Any of the following cardiovascular conditions:
a. History of significant cardiac (e.g. coronary heart disease, myocarditis, cardiomyopathy, heart failure NYHA II-IV) condition;
b. History of syncope;
c. Resting heart rate < 55 beat/min based on ECG at Visit 9 predose or history of any cardiac conditions that might increase the risk of a significant reduction in heart rate (e.g. any delay in the cardiac stimulus conduction on ECG);
d. Any medical condition that poses a significant risk of predisposing a patient to induction of cardiac arrhythmias (e.g. status post catheter ablation, hyperkalemia [defined as 2 consecutive measures of K+ above 6.0 mEq/L]).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this 225-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 13, 16, 20, 4, 27, 29, Follow up Visit 30 and Early Termination Visit will be compared with that of the baseline of the Extension Study<br><br>;Timepoint(s) of evaluation of this end point: Weeks 13, 16, 20, 4, 27, 29, Follow up Visit 30 and Early Termination Visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A