Clinical Trial Details

NCT ID: NCT02634307
Date Last Changed: August 3, 2017

Overview

Research Study Summary

A clinical research study of ALKS 8700 for the treatment of Multiple Sclerosis (MS) (the EVOLVE-1 Study)

Research Study 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

Purpose

This study will evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Alkermes, Inc.
Duration
60 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 65 Years

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

Site Locations (62)

Country State City Zip Facility and Contact
United States Alabama Cullman 35058 Alkermes Investigational Site
United States Arizona Phoenix 85004 Alkermes Investigational Site
United States Arizona Tucson 85704 Alkermes Investigational Site
United States California Berkeley 94705 Alkermes Investigational Site
United States California Long Beach 90806 Alkermes Investigational Site
United States California San Diego 92103 Alkermes Investigational Site
United States Colorado Basalt 81621 Alkermes Investigational Site
United States Colorado Centennial 80111 Alkermes Investigational Site
United States Colorado Denver 80209 Alkermes Investigational Site
United States Connecticut Middlebury 06762 Alkermes Investigational Site
United States Connecticut Stamford 06905 Alkermes Investigational Site
United States District of Columbia Washington, D.C. 20007 Alkermes Investigational Site
United States Florida Atlantis 33462 Alkermes Investigational Site
United States Florida Bradenton 34209 Alkermes Investigational Site
United States Florida Maitland 32751 Alkermes Investigational Site
United States Florida Naples 34102 Alkermes Investigational Site
United States Florida Ormond Beach 32174 Alkermes Investigational Site
United States Florida Sarasota 34239 Alkermes Investigational Site
United States Florida Tampa 33634 Alkermes Investigational Site
United States Florida Vero Beach 32960 Alkermes Investigational Site
United States Georgia Atlanta 30309 Alkermes Investigational Site
United States Georgia Atlanta 30312-4201 Alkermes Investigational Site
United States Georgia Columbus 31904 Alkermes Investigational Site
United States Illinois Evanston 60201 Alkermes Investigational Site
United States Indiana Indianapolis 46202 Alkermes Investigational Site
United States Iowa Des Moines 50314 Alkermes Investigational Site
United States Kansas Lenexa 66214 Alkermes Investigational Site
United States Kentucky Lexington 40513 Alkermes Investigational Site
United States Louisiana Alexandria 71301 Alkermes Investigational Site
United States Michigan Traverse City 49684 Alkermes Investigational Site
United States Minnesota Golden Valley 55422 Alkermes Investigational Site
United States Missouri Saint Louis 63104 Alkermes Investigational Site
United States Missouri Saint Louis 63110 Alkermes Investigational Site
United States New Mexico Albuquerque 87106 Alkermes Investigational Site
United States New York Patchogue 11772 Alkermes Investigational Site
United States New York Plainview 11803 Alkermes Investigational Site
United States New York Stony Brook 11794 Alkermes Investigational Site
United States North Carolina Charlotte 28203 Alkermes Investigational Site
United States North Carolina Greensboro 27405 Alkermes Investigational Site
United States North Carolina Raleigh 27607 Alkermes Investigational Site
United States North Carolina Winston-Salem 27103 Alkermes Investigational Site
United States Ohio Canton 44718 Alkermes Investigational Site
United States Ohio Columbus 43210 Alkermes Investigational Site
United States Oregon Medford 97504 Alkermes Investigational Site
United States Pennsylvania Philadelphia 19107 Alkermes Investigational Site
United States South Carolina Charleston 29406 Alkermes Investigational Site
United States South Carolina Greer 29650 Alkermes Investigational Site
United States South Carolina Indian Land 29707 Alkermes Investigational Site
United States South Carolina Spartanburg 29307 Alkermes Investigational Site
United States Tennessee Cordova 38018 Alkermes Investigational Site
United States Tennessee Franklin 37064 Alkermes Investigational Site
United States Tennessee Knoxville 37922 Alkermes Investigational Site
United States Texas Dallas 75231 Alkermes Investigational Site
United States Texas Houston 77030 Alkermes Investigational Site
United States Texas Houston 77074 Alkermes Investigational Site
United States Texas Lubbock 79410 Alkermes Investigational Site
United States Utah Salt Lake City 84103 Alkermes Investigational Site
United States Virginia Newport News 23601 Alkermes Investigational Site
United States Virginia Richmond 23228 Alkermes Investigational Site
United States Washington Seattle 98101 Alkermes Investigational Site
United States Washington Seattle 98122 Alkermes Investigational Site
United States Washington Seattle 98133 Alkermes Investigational Site

Contact

Alice Ann Freeman
919-334-3647
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.