A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:1/17/2019
Start Date:March 15, 2017
End Date:June 2019
Contact:Cynthia Rajan
Email:cynthia.rajan@syneoshealth.com
Phone:919-745-2658

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A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate

This study will assess the gastrointestinal (GI) tolerability of ALKS 8700 in adult subjects
with RRMS


Inclusion Criteria:

- 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

- Additional criteria may apply

Exclusion Criteria:

- 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)

- Additional criteria may apply
We found this trial at
53
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San Diego, California 92123
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Albuquerque, New Mexico
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Alexandria, Louisiana 71301
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Atlanta, Georgia 30308
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Atlantis, Florida 33462
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Basalt, Colorado 81621
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Bradenton, Florida 34201
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Canton, Ohio 44718
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Centennial, Colorado 80111
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28204
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Columbus, Georgia 31904
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Columbus, Ohio 43210
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Cullman, Alabama 35058
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Dallas, Texas 75231
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Dayton, Ohio 45417
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Des Moines, Iowa 50314
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Detroit, Michigan 47201
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Evanston, Illinois 60201
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Franklin, Tennessee 37064
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Golden Valley, Minnesota 55422
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Greensboro, North Carolina 27405
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Greer, South Carolina 29650
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Houston, Texas 77007
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Indian Land, South Carolina 29707
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Indianapolis, Indiana
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Knoxville, Tennessee 37922
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Lenexa, Kansas 66214
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Long Beach, California 90822
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Maitland, Florida 32751
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Middlebury, Connecticut 06762
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Naples, Florida 34102
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Newport News, Virginia 23601
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Ormond Beach, Florida 32174
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Patchogue, New York 11772
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Raleigh, North Carolina 27612
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Richmond, Virginia 23228
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Saint Louis, Missouri 63104
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Sarasota, Florida 34239
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Seattle, Washington
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Spartanburg, South Carolina 29307
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Stamford, Connecticut 06905
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Stony Brook, New York 11794
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Syracuse, New York 13210
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Tucson, Arizona 85712
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Vero Beach, Florida 32960
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Washington, District of Columbia 20016
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Winston-Salem, North Carolina 27103
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