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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) (an EVOLVE-MS Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Alkermes, Inc.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT02634307
First received: December 16, 2015
Last updated: April 19, 2017
Last verified: April 2017
  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: No masking
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: 800
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02634307

Contacts
Contact: Terri Ledford 919-926-6286 terri.ledford@incresearch.com

  Show 102 Study Locations
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
Study First Received: December 16, 2015
Last Updated: April 19, 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

ClinicalTrials.gov processed this record on May 25, 2017