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Trial record 1 of 3 for:    ALKS 8700
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A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

This study is currently recruiting participants.
Verified September 2017 by Alkermes, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02634307
First Posted: December 18, 2015
Last Update Posted: September 18, 2017
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.
Information provided by (Responsible Party):
Alkermes, Inc.
  Purpose
This study will evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

Condition Intervention Phase
Multiple Sclerosis Drug: ALKS 8700 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Safety will be demonstrated by incidence of Adverse Events [ Time Frame: Up to 96 weeks ]
    All enrolled subjects who receive at least one dose of ALKS 8700 will be used in the safety and tolerability analysis


Estimated Enrollment: 935
Study Start Date: December 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALKS 8700
Oral capsules
Drug: ALKS 8700
Capsules taken twice daily

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a confirmed diagnosis of RRMS
  • Neurologically stable with no evidence of relapse within 30 days prior to Visit 2
  • Additional criteria may apply

Exclusion Criteria:

  • 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
  • Diagnosis of primary progressive secondary progressive, or progressive relapsing MS
  • History of clinically significant cardiovascular, pulmonary, gastrointestinal (inflammatory bowel disease [IBD]; Crohn's disease, ulcerative colitis), dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial
  • History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina
  • Additional criteria may apply
  Contacts and Locations
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): NCT02634307


Contacts
Contact: Alice Ann Freeman 919-334-3647 AliceAnn.Freeman@INCResearch.com

  Hide Study Locations
Locations
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 Withdrawn
Phoenix, Arizona, United States, 85018
Alkermes Investigational Site Recruiting
Tucson, Arizona, United States, 85704
United States, California
Alkermes Investigational Site Recruiting
Berkeley, California, United States, 94705
Alkermes Investigational Site Active, not recruiting
Loma Linda, California, United States, 92354
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, 80111
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, D.C., 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 Withdrawn
Jacksonville, Florida, United States, 32209
Alkermes Investigational Site Recruiting
Maitland, Florida, United States, 32751
Alkermes Investigational Site Recruiting
Naples, Florida, United States, 34102
Alkermes Investigational Site Recruiting
Ormond Beach, Florida, United States, 32174
Alkermes Investigational Site Recruiting
Sarasota, Florida, United States, 34239
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 Recruiting
Atlanta, Georgia, United States, 30309
Alkermes Investigational Site Recruiting
Atlanta, Georgia, United States, 30312-4201
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, 46202
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, Kentucky
Alkermes Investigational Site Recruiting
Lexington, Kentucky, United States, 40513
United States, Louisiana
Alkermes Investigational Site Recruiting
Alexandria, Louisiana, United States, 71301
Alkermes Investigational Site Withdrawn
Baton Rouge, Louisiana, United States, 70810
United States, Michigan
Alkermes Investigational Site Recruiting
Traverse City, Michigan, United States, 49684
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
Plainview, New York, United States, 11803
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 Recruiting
Charlotte, North Carolina, United States, 28203
Alkermes Investigational Site Recruiting
Greensboro, North Carolina, United States, 27405
Alkermes Investigational Site Recruiting
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 Recruiting
Columbus, Ohio, United States, 43210
Alkermes Investigational Site Recruiting
Dayton, Ohio, United States, 45417
United States, Oklahoma
Alkermes Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Alkermes Investigational Site Recruiting
Medford, Oregon, United States, 97504
United States, Pennsylvania
Alkermes Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Alkermes Investigational Site Withdrawn
Providence, Rhode Island, United States, 02916
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
Cordova, Tennessee, United States, 38018
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
Alkermes Investigational Site Recruiting
Lubbock, Texas, United States, 79410
United States, Utah
Alkermes Investigational Site Recruiting
Salt Lake City, Utah, United States, 84103
United States, Virginia
Alkermes Investigational Site Recruiting
Newport News, Virginia, United States, 23601
Alkermes Investigational Site Recruiting
Richmond, Virginia, United States, 23228
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
Belgium
Alkermes Investigational Site Active, not recruiting
Fraiture, Belgium, 4557
Alkermes Investigational Site Active, not recruiting
La Louviere, Belgium, 7100
Alkermes Investigational Site Active, not recruiting
Overpelt, Belgium, 3900
Bulgaria
Alkermes Investigational Site Active, not recruiting
Blagoevgrad, Bulgaria, 2700
Alkermes Investigational Site Active, not recruiting
Pleven, Bulgaria, 5800
Alkermes Investigational Site Active, not recruiting
Sofia, Bulgaria, 1309
Alkermes Investigational Site Active, not recruiting
Sofia, Bulgaria, 1606
Alkermes Investigational Site Active, not recruiting
Sofia, Bulgaria, 1797
Germany
Alkermes Investigational Site Active, not recruiting
Berlin, Germany, 10713
Alkermes Investigational Site Active, not recruiting
Berlin, Germany, 12099
Alkermes Investigational Site Active, not recruiting
Dresden, Germany, 01307
Alkermes Investigational Site Active, not recruiting
Leipzig, Germany, 4103
Alkermes Investigational Site Active, not recruiting
Ulm, Germany, 89073
Alkermes Investigational Site Active, not recruiting
Ulm, Germany, 89081
Alkermes Investigational Site Active, not recruiting
Westerstede, Germany, 26655
Poland
Alkermes Investigational Site Active, not recruiting
Gdansk, Poland, 80-803
Alkermes Investigational Site Active, not recruiting
Katowice, Poland, 40-123
Alkermes Investigational Site Active, not recruiting
Katowice, Poland, 40-648
Alkermes Investigational Site Active, not recruiting
Krakow, Poland, 31-505
Alkermes Investigational Site Active, not recruiting
Lodz, Poland, 90-324
Alkermes Investigational Site Active, not recruiting
Lublin, Poland, 20-718
Alkermes Investigational Site Active, not recruiting
Plewiska, Poland, 62-064
Alkermes Investigational Site Active, not recruiting
Szczecin, Poland, 70-111
Alkermes Investigational Site Active, not recruiting
Świętokrzyskie, Poland, 25-726
Russian Federation
Alkermes Investigational Site Active, not recruiting
Krasnoyarsk, Russian Federation, 66037
Alkermes Investigational Site Active, not recruiting
Nizhniy Novgorod, Russian Federation, 603155
Serbia
Alkermes Investigational Site Active, not recruiting
Belgrade, Serbia, 11000
Alkermes Investigational Site Active, not recruiting
Kragujevac, Serbia, 34000
Alkermes Investigational Site Active, not recruiting
Nis, Serbia, 18000
Spain
Alkermes Investigational Site Active, not recruiting
Barcelona, Spain, 08916
Alkermes Investigational Site Active, not recruiting
Getafe-Madrid, Spain, 28905
Alkermes Investigational Site Active, not recruiting
Santa Cruz de Tenerife, Spain, 38010
Ukraine
Alkermes Investigational Site Active, not recruiting
Dnepropetrovsk, Ukraine, 49005
Alkermes Investigational Site Active, not recruiting
Ivano-Frankivsk, Ukraine, 76008
Alkermes Investigational Site Active, not recruiting
Kharkiv, Ukraine, 61068
Alkermes Investigational Site Active, not recruiting
Kharkiv, Ukraine, 61103
Alkermes Investigational Site Active, not recruiting
Lviv, Ukraine, 79000
Alkermes Investigational Site Active, not recruiting
Odessa, Ukraine, 65025
Alkermes Investigational Site Active, not recruiting
Zaporizhzhya, Ukraine, 69035
Alkermes Investigational Site Active, not recruiting
Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Richard Leigh-Pemberton, MD Alkermes, Inc.
  More Information

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02634307     History of Changes
Other Study ID Numbers: ALK8700-A301
First Submitted: December 16, 2015
First Posted: December 18, 2015
Last Update Posted: September 18, 2017
Last Verified: September 2017

Keywords provided by Alkermes, Inc.:
Multiple Sclerosis
MS
Relapsing Remitting Multiple Sclerosis
RRMS
dimethyl fumarate
DMF

Additional relevant 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


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