Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03093324
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will assess the gastrointestinal (GI) tolerability of ALKS 8700 in adult subjects with RRMS

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: ALKS 8700 Drug: Dimethyl Fumarate Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 8700
Capsules, administered orally
Drug: ALKS 8700
Oral capsules, administered twice daily

Active Comparator: Dimethyl Fumarate
Capsules, administered orally
Drug: Dimethyl Fumarate
Oral capsules, administered twice daily
Other Name: Tecfidera




Primary Outcome Measures :
  1. Number of days with GI events using an individual GI symptom scale [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Number of days with a GI symptom intensity score using an individual GI symptom scale [ Time Frame: 5 weeks ]
  2. Number of days with overall GI symptoms using a global GI symptom scale [ Time Frame: 5 weeks ]
  3. Worst GI symptom intensity by week using an individual GI symptom scale [ Time Frame: 5 weeks ]
  4. Safety will be measured by incidence of adverse events (AEs) [ Time Frame: 5 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093324


Contacts
Layout table for location contacts
Contact: Cynthia Rajan 919-745-2658 cynthia.rajan@syneoshealth.com

  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Alkermes Investigational Site Recruiting
Cullman, Alabama, United States, 35058
United States, Arizona
Alkermes Investigational Site Recruiting
Phoenix, Arizona, United States, 85004
Alkermes Investigational Site Recruiting
Tucson, Arizona, United States, 85704
United States, California
Alkermes Investigational Site Recruiting
Long Beach, California, United States, 90806
Alkermes Investigational Site Recruiting
San Diego, California, United States, 92103
United States, Colorado
Alkermes Investigational Site Recruiting
Basalt, Colorado, United States, 81621
Alkermes Investigational Site Recruiting
Centennial, Colorado, United States, 80112
Alkermes Investigational Site Recruiting
Denver, Colorado, United States, 80209
United States, Connecticut
Alkermes Investigational Site Recruiting
Middlebury, Connecticut, United States, 06762
Alkermes Investigational Site Recruiting
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Alkermes Investigational Site Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Alkermes Investigational Site Recruiting
Atlantis, Florida, United States, 33462
Alkermes Investigational Site Recruiting
Bradenton, Florida, United States, 34209
Alkermes Investigational Site Recruiting
Maitland, Florida, United States, 32751
Alkermes Investigational Site Recruiting
Naples, Florida, United States, 34105
Alkermes Investigational Site Recruiting
Ormond Beach, Florida, United States, 32174
Alkermes Investigational Site Recruiting
Sarasota, Florida, United States, 34233
Alkermes Investigational Site Recruiting
Tampa, Florida, United States, 33634
Alkermes Investigational Site Recruiting
Vero Beach, Florida, United States, 32960
United States, Georgia
Alkermes Investigational Site Completed
Atlanta, Georgia, United States, 30312
Alkermes Investigational Site Recruiting
Atlanta, Georgia, United States, 30327
Alkermes Investigational Site Recruiting
Atlanta, Georgia, United States, 30342
Alkermes Investigational Site Recruiting
Columbus, Georgia, United States, 31904
United States, Illinois
Alkermes Investigational Site Recruiting
Evanston, Illinois, United States, 60201
United States, Indiana
Alkermes Investigational Site Withdrawn
Indianapolis, Indiana, United States, 46260
United States, Iowa
Alkermes Investigational Site Recruiting
Des Moines, Iowa, United States, 50314
United States, Kansas
Alkermes Investigational Site Recruiting
Lenexa, Kansas, United States, 66214
United States, Louisiana
Alkermes Investigational Site Recruiting
Alexandria, Louisiana, United States, 71301
United States, Michigan
Alkermes Investigational Site Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Alkermes Investigational Site Recruiting
Golden Valley, Minnesota, United States, 55422
United States, Missouri
Alkermes Investigational Site Recruiting
Saint Louis, Missouri, United States, 63104
Alkermes Investigational Site Recruiting
Saint Louis, Missouri, United States, 63110
Alkermes Investigational Site Recruiting
Saint Louis, Missouri, United States, 63131
United States, New Mexico
Alkermes Investigational Site Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Alkermes Investigational Site Recruiting
Patchogue, New York, United States, 11772
Alkermes Investigational Site Recruiting
Stony Brook, New York, United States, 11794
Alkermes Investigational Site Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Alkermes Investigational Site Completed
Charlotte, North Carolina, United States, 28203
Alkermes Investigational Site Recruiting
Greensboro, North Carolina, United States, 27405
Alkermes Investigational Site Withdrawn
Raleigh, North Carolina, United States, 27607
Alkermes Investigational Site Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Alkermes Investigational Site Recruiting
Canton, Ohio, United States, 44718
Alkermes Investigational Site Completed
Columbus, Ohio, United States, 43221
Alkermes Investigational Site Recruiting
Dayton, Ohio, United States, 45417
United States, Oklahoma
Alkermes Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Alkermes Investigational Site Recruiting
Charleston, South Carolina, United States, 29406
Alkermes Investigational Site Recruiting
Greer, South Carolina, United States, 29650
Alkermes Investigational Site Recruiting
Indian Land, South Carolina, United States, 29707
Alkermes Investigational Site Recruiting
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Alkermes Investigational Site Recruiting
Franklin, Tennessee, United States, 37064
Alkermes Investigational Site Recruiting
Knoxville, Tennessee, United States, 37922
United States, Texas
Alkermes Investigational Site Recruiting
Dallas, Texas, United States, 75231
Alkermes Investigational Site Recruiting
Houston, Texas, United States, 77030
Alkermes Investigational Site Recruiting
Houston, Texas, United States, 77074
United States, Virginia
Alkermes Investigational Site Recruiting
Newport News, Virginia, United States, 23601
Alkermes Investigational Site Recruiting
Richmond, Virginia, United States, 23226
United States, Washington
Alkermes Investigational Site Recruiting
Seattle, Washington, United States, 98101
Alkermes Investigational Site Recruiting
Seattle, Washington, United States, 98122
Alkermes Investigational Site Recruiting
Seattle, Washington, United States, 98133
Poland
Alkermes Investigational Site Recruiting
Gdańsk, Poland, 80-803
Alkermes Investigational Site Recruiting
Katowice, Poland, 40-123
Alkermes Investigational Site Recruiting
Kielce, Poland, 25-726
Alkermes Investigational Site Recruiting
Lodz, Poland, 90-324
Alkermes Investigational Site Recruiting
Plewiska, Poland, 62-064
Alkermes Investigational Site Recruiting
Szczecin, Poland, 70-111
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Layout table for investigator information
Study Director: Richard Leigh-Pemberton, MD Alkermes, Inc.

Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT03093324     History of Changes
Other Study ID Numbers: ALK8700-A302
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alkermes, Inc.:
Relapsing Remitting Multiple Sclerosis
RRMS
Multiple Sclerosis
MS
Alkermes
ALKS 8700
Dimethyl Fumarate
DMF
Tecfidera

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs