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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 : March 13, 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

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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.


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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
Show Show 115 study locations
Sponsors and Collaborators
Biogen
Alkermes, Inc.
Investigators
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Study Director: Medical Director Biogen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: March 13, 2020
Last Verified: March 2020
Keywords provided by Biogen:
MS
Relapsing Remitting Multiple Sclerosis
RRMS
dimethyl fumarate
DMF
Additional relevant MeSH terms:
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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