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
Atlantis, Florida 33462
2696
mi
from 98109
Atlantis, FL
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Albuquerque, New Mexico
1186
mi
from 98109
Albuquerque, NM
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Alexandria, Louisiana 71301
1933
mi
from 98109
Alexandria, LA
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Atlanta, Georgia 30308
2178
mi
from 98109
Atlanta, GA
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Basalt, Colorado 81621
953
mi
from 98109
Basalt, CO
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Bradenton, Florida 34201
2552
mi
from 98109
Bradenton, FL
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Canton, Ohio 44718
2057
mi
from 98109
Canton, OH
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Centennial, Colorado 80111
1032
mi
from 98109
Centennial, CO
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Charleston, South Carolina 29407
2423
mi
from 98109
Charleston, SC
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Charlotte, North Carolina 28204
2282
mi
from 98109
Charlotte, NC
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Columbus, Georgia 31904
2207
mi
from 98109
Columbus, GA
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Columbus, Ohio 43210
2008
mi
from 98109
Columbus, OH
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Cullman, Alabama 35058
2049
mi
from 98109
Cullman, AL
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Dallas, Texas 75231
1677
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from 98109
Dallas, TX
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Dayton, Ohio 45417
1956
mi
from 98109
Dayton, OH
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1020
mi
from 98109
Denver, CO
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Des Moines, Iowa 50314
1463
mi
from 98109
Des Moines, IA
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Detroit, Michigan 47201
1933
mi
from 98109
Detroit, MI
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Evanston, Illinois 60201
1725
mi
from 98109
Evanston, IL
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Franklin, Tennessee 37064
1976
mi
from 98109
Franklin, TN
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?
mi
from 98109
Gda?sk,
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Golden Valley, Minnesota 55422
1386
mi
from 98109
Golden Valley, MN
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Greensboro, North Carolina 27405
2297
mi
from 98109
Greensboro, NC
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Greer, South Carolina 29650
2229
mi
from 98109
Greer, SC
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Houston, Texas 77007
1887
mi
from 98109
Houston, TX
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Indian Land, South Carolina 29707
2291
mi
from 98109
Indian Land, SC
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Indianapolis, Indiana
1868
mi
from 98109
Indianapolis, IN
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Knoxville, Tennessee 37922
2110
mi
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Knoxville, TN
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Lenexa, Kansas 66214
1502
mi
from 98109
Lenexa, KS
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Long Beach, California 90822
979
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from 98109
Long Beach, CA
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Maitland, Florida 32751
2543
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from 98109
Maitland, FL
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Middlebury, Connecticut 06762
2416
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from 98109
Middlebury, CT
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Naples, Florida 34102
2643
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from 98109
Naples, FL
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Newport News, Virginia 23601
2419
mi
from 98109
Newport News, VA
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Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Ormond Beach, Florida 32174
2527
mi
from 98109
Ormond Beach, FL
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Patchogue, New York 11772
2446
mi
from 98109
Patchogue, NY
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1116
mi
from 98109
Phoenix, AZ
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Raleigh, North Carolina 27612
2356
mi
from 98109
Raleigh, NC
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Richmond, Virginia 23228
2346
mi
from 98109
Richmond, VA
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Saint Louis, Missouri 63104
1721
mi
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Saint Louis, MO
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San Diego, California 92123
1059
mi
from 98109
San Diego, CA
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Sarasota, Florida 34239
2553
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Sarasota, FL
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Seattle, Washington
2
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Seattle, WA
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Spartanburg, South Carolina 29307
2242
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Spartanburg, SC
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Stamford, Connecticut 06905
2412
mi
from 98109
Stamford, CT
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Stony Brook, New York 11794
2139
mi
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Stony Brook, NY
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Syracuse, New York 13210
2231
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Syracuse, NY
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2527
mi
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Tampa, FL
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Tucson, Arizona 85712
1220
mi
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Tucson, AZ
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Vero Beach, Florida 32960
2633
mi
from 98109
Vero Beach, FL
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Washington, District of Columbia 20016
2322
mi
from 98109
Washington,
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Winston-Salem, North Carolina 27103
2275
mi
from 98109
Winston-Salem, NC
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