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

Last updated: July 13, 2020
Sponsor: Biogen
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

Memory Loss

Treatment

N/A

Clinical Study ID

NCT03093324
ALK8700-A302
2017-001294-16
  • Ages 18-65
  • All Genders

Study Summary

The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.

Eligibility Criteria

Inclusion

Key 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 torandomization

  • Agrees to use an acceptable method of contraception for the duration of the study andfor 30 days after any study drug administration, or is surgically sterile orpost-menopausal

Exclusion

Key Exclusion Criteria:

  • Have any finding(s) that would compromise the safety of the subject, affect thesubject's ability to adhere to the protocol visit schedule or to fulfill visitrequirements, 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 diseasethat would preclude participation in a clinical trial

  • History of GI surgery (except appendectomy that occurred more than 6 months prior toscreening

  • 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 ofscreening Has a clinically significant medical condition or observed abnormality atscreening

  • History of a myocardial infarction, including a silent myocardial infarction orunstable angina

  • History of clinically significant drug or alcohol abuse within the past year prior toscreening

  • 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 beginbreastfeeding at any point during the study and for 30 days after any study drugadministration

  • Prior use of Dimethyl Fumarate (DMF) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 506
Study Start date:
March 15, 2017
Estimated Completion Date:
June 27, 2019

Connect with a study center

  • Alkermes Investigational Site

    Dresden,
    Germany

    Site Not Available

  • Alkermes Investigational Site

    Leipzig,
    Germany

    Site Not Available

  • Alkermes Investigational Site

    Ulm,
    Germany

    Site Not Available

  • Alkermes Investigational Site

    Westerstede,
    Germany

    Site Not Available

  • Alkermes Investigational Site

    Gdańsk, 80-803
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Katowice, 40-123
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Kielce, 25-726
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Lodz, 90-324
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Plewiska, 62-064
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Szczecin, 70-111
    Poland

    Site Not Available

  • Alkermes Investigational Site

    Cullman, Alabama 35058
    United States

    Site Not Available

  • Alkermes Investigational Site

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Alkermes Investigational Site

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Alkermes Investigational Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Diego, California 92103
    United States

    Site Not Available

  • Alkermes Investigational Site

    Basalt, Colorado 81621
    United States

    Site Not Available

  • Alkermes Investigational Site

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Alkermes Investigational Site

    Denver, Colorado 80209
    United States

    Site Not Available

  • Alkermes Investigational Site

    Middlebury, Connecticut 06762
    United States

    Site Not Available

  • Alkermes Investigational Site

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, D.C., District of Columbia 20007
    United States

    Site Not Available

  • Alkermes Investigational Site

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Alkermes Investigational Site

    Bradenton, Florida 34209
    United States

    Site Not Available

  • Alkermes Investigational Site

    Maitland, Florida 32751
    United States

    Site Not Available

  • Alkermes Investigational Site

    Naples, Florida 34105
    United States

    Site Not Available

  • Alkermes Investigational Site

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Alkermes Investigational Site

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Alkermes Investigational Site

    Tampa, Florida 33634
    United States

    Site Not Available

  • Alkermes Investigational Site

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Alkermes Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Alkermes Investigational Site

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Alkermes Investigational Site

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Alkermes Investigational Site

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lenexa, Kansas 66214
    United States

    Site Not Available

  • Alkermes Investigational Site

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Alkermes Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Alkermes Investigational Site

    Golden Valley, Minnesota 55422
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Luis, Missouri 63131
    United States

    Site Not Available

  • Alkermes Investigational Site

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Alkermes Investigational Site

    Patchogue, New York 11772
    United States

    Site Not Available

  • Alkermes Investigational Site

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Alkermes Investigational Site

    Syracuse, New York 13210
    United States

    Site Not Available

  • Alkermes Investigational Site

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Alkermes Investigational Site

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Alkermes Investigational Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Alkermes Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Alkermes Investigational Site

    Canton, Ohio 44718
    United States

    Site Not Available

  • Alkermes Investigational Site

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Alkermes Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Alkermes Investigational Site

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Alkermes Investigational Site

    Greer, South Carolina 29650
    United States

    Site Not Available

  • Alkermes Investigational Site

    Indian Land, South Carolina 29707
    United States

    Site Not Available

  • Alkermes Investigational Site

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • Alkermes Investigational Site

    Franklin, Tennessee 37064
    United States

    Site Not Available

  • Alkermes Investigational Site

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Alkermes Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Alkermes Investigational Site

    Newport News, Virginia 23601
    United States

    Site Not Available

  • Alkermes Investigational Site

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Alkermes Investigational Site

    Seattle, Washington 98101
    United States

    Site Not Available

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