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
Franklin, Tennessee 37064
618
mi
from
Franklin, TN
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Albuquerque, New Mexico
521
mi
from
Albuquerque, NM
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Alexandria, Louisiana 71301
539
mi
from
Alexandria, LA
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Atlanta, Georgia 30308
801
mi
from
Atlanta, GA
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Atlantis, Florida 33462
1287
mi
from
Atlantis, FL
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Basalt, Colorado 81621
509
mi
from
Basalt, CO
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Bradenton, Florida 34201
1142
mi
from
Bradenton, FL
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Canton, Ohio 44718
903
mi
from
Canton, OH
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Centennial, Colorado 80111
400
mi
from
Centennial, CO
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Charleston, South Carolina 29407
1063
mi
from
Charleston, SC
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Charlotte, North Carolina 28204
958
mi
from
Charlotte, NC
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Columbus, Georgia 31904
811
mi
from
Columbus, GA
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Columbus, Ohio 43210
810
mi
from
Columbus, OH
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Cullman, Alabama 35058
661
mi
from
Cullman, AL
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Dayton, Ohio 45417
741
mi
from
Dayton, OH
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409
mi
from
Denver, CO
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Des Moines, Iowa 50314
347
mi
from
Des Moines, IA
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Detroit, Michigan 47201
841
mi
from
Detroit, MI
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Evanston, Illinois 60201
612
mi
from
Evanston, IL
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?
mi
from
Gda?sk,
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Golden Valley, Minnesota 55422
552
mi
from
Golden Valley, MN
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Greensboro, North Carolina 27405
1001
mi
from
Greensboro, NC
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Greer, South Carolina 29650
888
mi
from
Greer, SC
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Houston, Texas 77007
567
mi
from
Houston, TX
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Indian Land, South Carolina 29707
962
mi
from
Indian Land, SC
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Indianapolis, Indiana
643
mi
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Indianapolis, IN
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Knoxville, Tennessee 37922
777
mi
from
Knoxville, TN
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Lenexa, Kansas 66214
186
mi
from
Lenexa, KS
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Long Beach, California 90822
1168
mi
from
Long Beach, CA
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Maitland, Florida 32751
1138
mi
from
Maitland, FL
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Middlebury, Connecticut 06762
1334
mi
from
Middlebury, CT
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Naples, Florida 34102
1232
mi
from
Naples, FL
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Newport News, Virginia 23601
1173
mi
from
Newport News, VA
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Oklahoma City, Oklahoma
158
mi
from
Oklahoma City, OK
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Ormond Beach, Florida 32174
1126
mi
from
Ormond Beach, FL
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Patchogue, New York 11772
1338
mi
from
Patchogue, NY
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852
mi
from
Phoenix, AZ
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Raleigh, North Carolina 27612
1064
mi
from
Raleigh, NC
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Richmond, Virginia 23228
1109
mi
from
Richmond, VA
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Saint Louis, Missouri 63104
418
mi
from
Saint Louis, MO
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San Diego, California 92123
1138
mi
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San Diego, CA
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Sarasota, Florida 34239
1142
mi
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Sarasota, FL
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Seattle, Washington
1410
mi
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Seattle, WA
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Spartanburg, South Carolina 29307
903
mi
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Spartanburg, SC
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Stamford, Connecticut 06905
1311
mi
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Stamford, CT
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Stony Brook, New York 11794
1048
mi
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Stony Brook, NY
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Syracuse, New York 13210
1193
mi
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Syracuse, NY
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1117
mi
from
Tampa, FL
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Tucson, Arizona 85712
830
mi
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Tucson, AZ
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Vero Beach, Florida 32960
1227
mi
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Vero Beach, FL
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Washington, District of Columbia 20016
1127
mi
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Washington,
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Winston-Salem, North Carolina 27103
976
mi
from
Winston-Salem, NC
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