Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
With
Alkermes, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Capable of understanding and complying with the protocol
Has a confirmed diagnosis of RRMS
Neurologically stable with no evidence of relapse within 30 days prior to randomization
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal
You may not be if
Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
History of a myocardial infarction, including a silent myocardial infarction or unstable angina
History of clinically significant drug or alcohol abuse within the past year prior to screening
Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
Prior use of Dimethyl Fumarate (DMF)
Clareo Health | A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
