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

Use our guide to learn which trials are right for you!

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
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Atlanta, Georgia 30308
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Basalt, Colorado 81621
?
mi
from
Basalt, CO
Click here to add this to my saved trials
Bradenton, Florida 34201
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Centennial, Colorado 80111
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cullman, Alabama 35058
?
mi
from
Cullman, AL
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45417
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 47201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Franklin, Tennessee 37064
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Gda?sk,
Click here to add this to my saved trials
Golden Valley, Minnesota 55422
?
mi
from
Golden Valley, MN
Click here to add this to my saved trials
Greensboro, North Carolina 27405
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greer, South Carolina 29650
?
mi
from
Greer, SC
Click here to add this to my saved trials
Houston, Texas 77007
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indian Land, South Carolina 29707
?
mi
from
Indian Land, SC
Click here to add this to my saved trials
Indianapolis, Indiana
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Knoxville, Tennessee 37922
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lenexa, Kansas 66214
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Long Beach, California 90822
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Middlebury, Connecticut 06762
?
mi
from
Middlebury, CT
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
Newport News, Virginia 23601
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Patchogue, New York 11772
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23228
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Saint Louis, Missouri 63104
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Seattle, Washington
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spartanburg, South Carolina 29307
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Stamford, Connecticut 06905
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tucson, Arizona 85712
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Vero Beach, Florida 32960
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials
Washington, District of Columbia 20016
?
mi
from
Washington,
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials