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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: ALKS 8700||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1057 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: ALKS 8700
Oral capsules taken twice daily.
Drug: ALKS 8700
Administered as specified in the treatment arm.
- Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to 98 weeks ]
- 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.
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
|Study Director:||Medical Director||Biogen|