CompletedPhase 3

A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

United States, Belgium, Bulgaria1,057 participantsStarted 2015-12-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit

Timeframe: Up to 98 weeks

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Trial details

NCT IDNCT02634307

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-01

Results submitted2022-05-30

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)

Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit

Timeframe: Up to 98 weeks

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

Timeframe: From first dose to two weeks after last dose of study drug (Up to 98 weeks)