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
sites
San Diego, California 92123
1947
mi
from 43215
San Diego, CA
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Albuquerque, New Mexico
1331
mi
from 43215
Albuquerque, NM
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Alexandria, Louisiana 71301
797
mi
from 43215
Alexandria, LA
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Atlanta, Georgia 30308
436
mi
from 43215
Atlanta, GA
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Atlantis, Florida 33462
939
mi
from 43215
Atlantis, FL
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Basalt, Colorado 81621
1273
mi
from 43215
Basalt, CO
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Bradenton, Florida 34201
868
mi
from 43215
Bradenton, FL
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Canton, Ohio 44718
104
mi
from 43215
Canton, OH
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Centennial, Colorado 80111
1157
mi
from 43215
Centennial, CO
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Charleston, South Carolina 29407
525
mi
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Charleston, SC
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Charlotte, North Carolina 28204
349
mi
from 43215
Charlotte, NC
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Columbus, Georgia 31904
529
mi
from 43215
Columbus, GA
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Columbus, Ohio 43210
1
mi
from 43215
Columbus, OH
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Cullman, Alabama 35058
451
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Cullman, AL
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Dayton, Ohio 45417
69
mi
from 43215
Dayton, OH
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1162
mi
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Denver, CO
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Des Moines, Iowa 50314
564
mi
from 43215
Des Moines, IA
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Detroit, Michigan 47201
163
mi
from 43215
Detroit, MI
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Evanston, Illinois 60201
282
mi
from 43215
Evanston, IL
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Franklin, Tennessee 37064
348
mi
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Franklin, TN
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?
mi
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Gda?sk,
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Golden Valley, Minnesota 55422
630
mi
from 43215
Golden Valley, MN
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Greensboro, North Carolina 27405
321
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from 43215
Greensboro, NC
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Greer, South Carolina 29650
350
mi
from 43215
Greer, SC
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Houston, Texas 77007
992
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from 43215
Houston, TX
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Indian Land, South Carolina 29707
365
mi
from 43215
Indian Land, SC
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Indianapolis, Indiana
166
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from 43215
Indianapolis, IN
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Knoxville, Tennessee 37922
280
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Knoxville, TN
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Lenexa, Kansas 66214
628
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from 43215
Lenexa, KS
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Long Beach, California 90822
1973
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from 43215
Long Beach, CA
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Maitland, Florida 32751
788
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from 43215
Maitland, FL
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Middlebury, Connecticut 06762
528
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from 43215
Middlebury, CT
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Naples, Florida 34102
957
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from 43215
Naples, FL
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Newport News, Virginia 23601
411
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from 43215
Newport News, VA
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Oklahoma City, Oklahoma
849
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from 43215
Oklahoma City, OK
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Ormond Beach, Florida 32174
746
mi
from 43215
Ormond Beach, FL
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Patchogue, New York 11772
529
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Patchogue, NY
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1662
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Phoenix, AZ
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Raleigh, North Carolina 27612
369
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Raleigh, NC
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Richmond, Virginia 23228
339
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Richmond, VA
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Saint Louis, Missouri 63104
394
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Saint Louis, MO
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Sarasota, Florida 34239
872
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Sarasota, FL
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Seattle, Washington
2006
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Seattle, WA
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Spartanburg, South Carolina 29307
351
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Spartanburg, SC
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Stamford, Connecticut 06905
503
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Stamford, CT
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Stony Brook, New York 11794
261
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Stony Brook, NY
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Syracuse, New York 13210
414
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Syracuse, NY
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830
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Tampa, FL
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Tucson, Arizona 85712
1636
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Tucson, AZ
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Vero Beach, Florida 32960
864
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Vero Beach, FL
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Washington, District of Columbia 20016
328
mi
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Washington,
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Winston-Salem, North Carolina 27103
306
mi
from 43215
Winston-Salem, NC
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