Working…
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

Tracking Information
First Submitted Date  ICMJE December 16, 2015
First Posted Date  ICMJE December 18, 2015
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE December 10, 2015
Estimated Primary Completion Date May 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to 98 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • Anualized Relapse Rate [ Time Frame: Up to 96 weeks ]
  • Percentage of Participants with MS Relapse [ Time Frame: Up to 96 weeks ]
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Official Title  ICMJE A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: ALKS 8700
Administered as specified in the treatment arm.
Study Arms  ICMJE Experimental: ALKS 8700
Oral capsules taken twice daily.
Intervention: Drug: ALKS 8700
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
1057
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2015)
600
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date May 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   Germany,   Poland,   Russian Federation,   Serbia,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02634307
Other Study ID Numbers  ICMJE ALK8700-A301
2015-005160-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Alkermes, Inc.
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP