Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    ALKS 8700
Previous Study | Return to List | Next Study

A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02634307
Recruitment Status : Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ALKS 8700 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1057 participants
Allocation: N/A
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
Actual Study Start Date : December 10, 2015
Estimated Primary Completion Date : May 17, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 8700
Oral capsules taken twice daily.
Drug: ALKS 8700
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to 98 weeks ]

Secondary Outcome Measures :
  1. Anualized Relapse Rate [ Time Frame: Up to 96 weeks ]
  2. Percentage of Participants with MS Relapse [ Time Frame: Up to 96 weeks ]
  3. Progression of Disability on the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1, 85,169, 253, 337, 421, 505, 589, 673 ]
    The EDSS is used to measure and evaluate MS patients' level of functioning. The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic examination; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS.

  4. Timed 25-foot Walk Test (T25-FW) Scores [ Time Frame: Day 1, 85,169, 253, 337, 421, 505, 589, 673 ]
    The T25-FW is a reliable quantitative mobility and leg function performance test based on a timed 25-foot walk. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. Subjects are allowed to use assistive devices (canes, crutches, walkers) as needed. The time is calculated from when the lead foot crosses the start point to when the subject has reached the 25-foot mark. The task is immediately administered again by having the subject walk back the same distance. The score for the T25-FW is the average of the 2 completed trials.

  5. EuroQol Group Health Outcome Measure (EQ-5D-5L) Score [ Time Frame: Day 1,169, 337, 505, 673 ]
    The EQ-5D-5L is an instrument designed to assess decrements in health. The EQ-5D-5L includes a Visual Analog Scale (VAS) and a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response categories corresponding to the level of severity (i.e., no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems).

  6. 12-item Short Form Health Survey (SF-12) [ Time Frame: Day 1, 169, 337, 505, 673 ]
    Quality of life will be assessed using the 12-item Short-Form health survey Version 2.



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

Key Inclusion Criteria:

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

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, 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

NOTE: Other protocol defined Includison/Exclusion 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): NCT02634307


Locations
Hide Hide 115 study locations
Layout table for location information
United States, Alabama
Alkermes Investigational Site
Cullman, Alabama, United States, 35058
United States, Arizona
Alkermes Investigational Site
Phoenix, Arizona, United States, 85004
Alkermes Investigational Site
Phoenix, Arizona, United States, 85018
Alkermes Investigational Site
Phoenix, Arizona, United States, 85032
Alkermes Investigational Site
Tucson, Arizona, United States, 85704
United States, California
Alkermes Investigational Site
Berkeley, California, United States, 94705
Alkermes Investigational Site
Loma Linda, California, United States, 92354
Alkermes Investigational Site
Long Beach, California, United States, 90806
Alkermes Investigational Site
San Diego, California, United States, 92103
United States, Colorado
Alkermes Investigational Site
Basalt, Colorado, United States, 81621
Alkermes Investigational Site
Centennial, Colorado, United States, 80111
Alkermes Investigational Site
Denver, Colorado, United States, 80209
United States, Connecticut
Alkermes Investigational Site
Middlebury, Connecticut, United States, 06762
Alkermes Investigational Site
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Alkermes Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Alkermes Investigational Site
Atlantis, Florida, United States, 33462
Alkermes Investigational Site
Bradenton, Florida, United States, 34209
Alkermes Investigational Site
Jacksonville, Florida, United States, 32209
Alkermes Investigational Site
Maitland, Florida, United States, 32751
Alkermes Investigational Site
Naples, Florida, United States, 34102
Alkermes Investigational Site
Ormond Beach, Florida, United States, 32174
Alkermes Investigational Site
Sarasota, Florida, United States, 34239
Alkermes Investigational Site
Tampa, Florida, United States, 33634
Alkermes Investigational Site
Vero Beach, Florida, United States, 32960
United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30312-4201
Alkermes Investigational Site
Atlanta, Georgia, United States, 30327
Alkermes Investigational Site
Atlanta, Georgia, United States, 30342
Alkermes Investigational Site
Columbus, Georgia, United States, 31904
United States, Illinois
Alkermes Investigational Site
Evanston, Illinois, United States, 60201
United States, Indiana
Alkermes Investigational Site
Indianapolis, Indiana, United States, 46202
Alkermes Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
Alkermes Investigational Site
Des Moines, Iowa, United States, 50314
United States, Kansas
Alkermes Investigational Site
Overland Park, Kansas, United States, 66213
United States, Kentucky
Alkermes Investigational Site
Lexington, Kentucky, United States, 40513
United States, Louisiana
Alkermes Investigational Site
Alexandria, Louisiana, United States, 71301
Alkermes Investigational Site
Baton Rouge, Louisiana, United States, 70810
United States, Michigan
Alkermes Investigational Site
Detroit, Michigan, United States, 48202
Alkermes Investigational Site
Traverse City, Michigan, United States, 49684
United States, Minnesota
Alkermes Investigational Site
Golden Valley, Minnesota, United States, 55422
United States, Missouri
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63104
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63110
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63131
United States, New Mexico
Alkermes Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
Alkermes Investigational Site
Patchogue, New York, United States, 11772
Alkermes Investigational Site
Plainview, New York, United States, 11803
Alkermes Investigational Site
Stony Brook, New York, United States, 11794
Alkermes Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
Alkermes Investigational Site
Charlotte, North Carolina, United States, 28203
Alkermes Investigational Site
Greensboro, North Carolina, United States, 27405
Alkermes Investigational Site
Raleigh, North Carolina, United States, 27607
Alkermes Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Alkermes Investigational Site
Canton, Ohio, United States, 44718
Alkermes Investigational Site
Columbus, Ohio, United States, 43210
Alkermes Investigational Site
Dayton, Ohio, United States, 45417
United States, Oklahoma
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Alkermes Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Alkermes Investigational Site
Charleston, South Carolina, United States, 29406
Alkermes Investigational Site
Greer, South Carolina, United States, 29650
Alkermes Investigational Site
Rock Hill, South Carolina, United States, 29732
Alkermes Investigational Site
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Alkermes Investigational Site
Cordova, Tennessee, United States, 38018
Alkermes Investigational Site
Franklin, Tennessee, United States, 37064
Alkermes Investigational Site
Knoxville, Tennessee, United States, 37922
United States, Texas
Alkermes Investigational Site
Dallas, Texas, United States, 75231
Alkermes Investigational Site
Houston, Texas, United States, 77030
Alkermes Investigational Site
Houston, Texas, United States, 77074
Alkermes Investigational Site
Lubbock, Texas, United States, 79410
United States, Utah
Alkermes Investigational Site
Salt Lake City, Utah, United States, 84103
United States, Virginia
Alkermes Investigational Site
Newport News, Virginia, United States, 23601
Alkermes Investigational Site
Richmond, Virginia, United States, 23228
United States, Washington
Alkermes Investigational Site
Seattle, Washington, United States, 98101
Alkermes Investigational Site
Seattle, Washington, United States, 98122
Alkermes Investigational Site
Seattle, Washington, United States, 98133
Belgium
Alkermes Investigational Site
Brugge, Belgium, 8000
Alkermes Investigational Site
Fraiture, Belgium, 4557
Alkermes Investigational Site
La Louviere, Belgium, 7100
Bulgaria
Alkermes Investigational Site
Blagoevgrad, Bulgaria, 2700
Alkermes Investigational Site
Pleven, Bulgaria, 5800
Alkermes Investigational Site
Sofia, Bulgaria, 1309
Alkermes Investigational Site
Sofia, Bulgaria, 1606
Alkermes Investigational Site
Sofia, Bulgaria, 1797
Canada, Quebec
Alkermes Investigational Site
Gatineau, Quebec, Canada, J8Y 1W2
Germany
Alkermes Investigational Site
Berlin, Germany, 10713
Alkermes Investigational Site
Berlin, Germany, 12099
Alkermes Investigational Site
Dresden, Germany, 01307
Alkermes Investigational Site
Leipzig, Germany, 4103
Alkermes Investigational Site
Ulm, Germany, 89073
Alkermes Investigational Site
Ulm, Germany, 89081
Alkermes Investigational Site
Westerstede, Germany, 26655
Poland
Alkermes Investigational Site
Gdansk, Poland, 80-803
Alkermes Investigational Site
Katowice, Poland, 40-123
Alkermes Investigational Site
Katowice, Poland, 40-648
Alkermes Investigational Site
Kielce, Poland, 25-726
Alkermes Investigational Site
Krakow, Poland, 31-505
Alkermes Investigational Site
Lodz, Poland, 90-324
Alkermes Investigational Site
Lublin, Poland, 20-718
Alkermes Investigational Site
Plewiska, Poland, 62-064
Alkermes Investigational Site
Szczecin, Poland, 70-111
Russian Federation
Alkermes Investigational Site
Krasnoyarsk, Russian Federation, 66037
Alkermes Investigational Site
Nizhniy Novgorod, Russian Federation, 603155
Serbia
Alkermes Investigational Site
Belgrade, Serbia, 11000
Alkermes Investigational Site
Kragujevac, Serbia, 34000
Alkermes Investigational Site
Nis, Serbia, 18000
Spain
Alkermes Investigational Site
Barcelona, Spain, 08916
Alkermes Investigational Site
Madrid, Spain, 28905
Alkermes Investigational Site
Santa Cruz de Tenerife, Spain, 38010
Ukraine
Alkermes Investigational Site
Dnipro, Ukraine, 49005
Alkermes Investigational Site
Ivano-Frankivsk, Ukraine, 76008
Alkermes Investigational Site
Kharkiv, Ukraine, 61068
Alkermes Investigational Site
Kharkiv, Ukraine, 61103
Alkermes Investigational Site
Lviv, Ukraine, 79000
Alkermes Investigational Site
Odessa, Ukraine, 65025
Alkermes Investigational Site
Zaporizhzhya, Ukraine, 69035
Alkermes Investigational Site
Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
Biogen
Alkermes, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02634307    
Other Study ID Numbers: ALK8700-A301
2015-005160-41 ( EudraCT Number )
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Keywords provided by Biogen:
MS
Relapsing Remitting Multiple Sclerosis
RRMS
dimethyl fumarate
DMF
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases