Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: Determine the efficacy, safety, and tolerability of BG00012 in MS patients.


Options:
A: Inclusion Criteria:

* Multiple sclerosis \[MS\] subject who was ambulatory (EDSS of ≤ 5.5)
* Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
* Meeting McDonald's criteria for MS diagnosis;
* Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
* No relapse onset in the preceding 60 days prior to randomization;
* Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone \[ACTH\] or systemic steroid treatment.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
* Significantly impaired bone marrow function;
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
B: Inclusion Criteria:

1. Must be 18 to 55 years old, inclusive, at the time of informed consent.
2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
3. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
4. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
5. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 \[Appendix 3\]).
2. History of malignancy.
3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
4. History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
5. History of human immunodeficiency virus (HIV).
6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
8. Body weight \>100 kg.
9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
10. Any of the following abnormal blood tests at screening.
11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.
12. A medication history that precludes entry into the study.
13. Female subjects who are currently pregnant or breast-feeding.
C: Inclusion Criteria:

* Informed consent
* Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
* Disability EDSS score of 4.0 or less at baseline
* Clinical activity as defined by at least one relapse in the last year

Exclusion Criteria:

* Relapse in the month prior to enrolment
* Treatment with immunosuppressive drugs for MS
* History of major depression
* Former severe reactions to corticosteroids
* Pregnant women
* Diabetes mellitus, and drug or alcohol dependency
* Known or suspected allergy to trial products
D: Inclusion Criteria:

* Male and female subjects between the ages of 18 and 60 years, inclusive.
* Diagnosis of relapsing-remitting MS by either the Poser or McDonald criteria.
* Expanded Disability Status Scale (EDSS) score between 0 and 5.5, inclusive.
* At least 2 exacerbations in the prior three years; one exacerbation may utilize the McDonald MRI criteria for dissemination in time (a new gadolinium \[Gd\]-enhancing lesion demonstrated on a scan done at least 3 months following onset of a clinical attack or a new T2 lesion or Gd-enhancing lesion on a follow-up scan after an additional 3 months).
* Give written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Exclusion Criteria:

* Any prior use of interferon beta or glatiramer acetate.
* Acute exacerbation within 30 days of screening.
* Steroids for acute exacerbations (\>100 mg/day) within 30 days of study entrance or chronic systemic steroid use.
* Evidence of progressive MS.
* Use IVIg, azathioprine, methotrexate, cyclosporine, mitoxantrone, cyclophosphamide, mycophenolate (CellCept) or plasma exchange in the twelve weeks prior to study drug dosing.
* Any previous treatment with natalizumab (Tysabri, Antegren), cladribine, T cell vaccine, Campath, daclizumab, rituximab, altered peptide ligand or total lymphoid irradiation.
* Treatment with 4 aminopyridines in the four weeks prior to study drug dosing.
* Prior treatment with any other investigational drug, unless approved by the Clinical Coordinating Center (Dr. Lublin).
* Inability to perform the baseline MSFC (timed 25-foot walk, 9-hole peg test \[9HPT\], and Paced Auditory Serial Addition Test 3 \[PASAT3\]).
* Inability to undergo baseline MRI scan.
* History of any significant cardiac, hepatic, pulmonary, or renal disease, immune deficiency, or other medical conditions that would preclude therapy with interferon beta, glatiramer acetate, or participation in this study.
* Known history of sensitivity to gadopentetate dimeglumine or mannitol.
* History of a seizure within the 3 months prior to randomization.
* History of suicidal ideation or an episode of severe depression within the 3 months prior to randomization.
* Abnormal screening blood tests exceeding any of the limits defined below:

  * Alanine transaminase (ALT) or aspartate transaminase (AST) greater than two times the upper limit of normal (i.e., \>2 × ULN)
  * Total white blood cell count \<2,300/mm3
  * Platelet count \<80,000/mm3
  * Creatinine \>2 × ULN
* Participation in another experimental clinical trial, without formal approval.
* History of alcohol or drug abuse within the 2 years prior to randomization.
* Female subjects who are currently pregnant, breast-feeding, or plan to become pregnant.
* For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception.
* Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition that is likely to affect the subject's returning for scheduled follow-up visits on schedule (any physical, mental, or social condition).

Answer: B