Phase
Condition
Neurologic Disorders
Memory Loss
Multiple Sclerosis
Treatment
N/AClinical Study ID
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Are pre-menopausal women with or without child-bearing potential with a negative serumpregnancy test, and women with child-bearing potential receiving adequate birthcontrol
Participants with diagnosis of clinically stable and definite relapsing multiplesclerosis (RMS)
Adequate hematological, hepatic and renal function as defined in the protocol
Are able and willing to accept dietary restrictions and restrictions regarding the useof concomitant medications (including over-the-counter products, herbal medicines anddietary supplements) over the course of the study
Have a body weight and body mass index (BMI) within the range at screening
Other protocol defined inclusion criteria could apply
Exclusion
Exclusion Criteria:
History of clinically relevant allergy or known hypersensitivity to the activesubstance or to any of the excipients of cladribine tablets or hypersensitivity todrugs with a similar chemical structure to cladribine - History of clinically relevantallergy or known hypersensitivity to 1 of the active substances levonorgestrel (LNG)or ethinylestradiol (EE) or to any excipients of Microgynon® tablets
Positive results from serology examination for Hepatitis B surface antigen (HbsAg) notdue to vaccination, hepatitis B core antibody (HbcAb), Hepatitis C virus antibody (anti- HCV) or Human Immunodeficiency antibody (anti-HIV)
Presence or risk of venous thromboembolism (VTE) arterial thromboembolism (ATE)
Diabetes mellitus (Type 1 or Type 2) with vascular manifestations
Signs or symptoms of neurological disease other than multiple sclerosis (MS) thatcould explain the symptoms of the participant
Presence of gastrointestinal (GI) disease or history of gastrointestinal -tractsurgery
Exposure to another investigational drug within the last 2 months or within last 6month if agent is known to be immunosuppressive
Other protocol defined exclusion criteria could apply
Study Design
Connect with a study center
St. Josef und St. Elisabeth Hospital gGmbH
Bochum, 44791
GermanyActive - Recruiting
Please Contact the Merck KGaA Communication Center
Darmstadt, 64293
GermanyActive - Recruiting
Nuvisan GmbH
Neu-Ulm, 89231
GermanyActive - Recruiting
Fachklinik für Neurologie Dietenbronn GmbH - Diagnostisches und therapeutisches Kompetenzzentrum für Multiple Sklerose
Ulm, 89081
GermanyActive - Recruiting
NeuroPoint
Ulm, 89073
GermanyActive - Recruiting
Universitätsklinikum Ulm (11785)
Ulm, 89081
GermanyActive - Recruiting
BioVirtus Research Site Sp (13013)
Otwock, 04-749
PolandActive - Recruiting
MTZ Clinical Research Sp. z o.o.
Warszawa, 02-106
PolandActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.