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Trial record 1 of 1 for:    ALK8700-A301
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A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

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ClinicalTrials.gov Identifier: NCT02634307
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 935 participants
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ALKS 8700
Oral capsules
Drug: ALKS 8700
Capsules taken twice daily



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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

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

  Show 113 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Richard Leigh-Pemberton, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02634307     History of Changes
Other Study ID Numbers: ALK8700-A301
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 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