an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005160-41-PL

Enrollment

1000

Registered

2016-04-13

Start date

2016-06-07

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule Pharmaceutical Form: Capsule INN or Proposed INN: Not available CAS Number: Not availabl Current Sponsor code: RDC-5108-00, ALKS

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 501 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) to evaluate the long-term safety and tolerability of ALKS 8700 for up to 96 weeks of treatment in adult subjects with relapsing remitting multiple sclerosis (RRMS);Secondary Objective: 2) to evaluate treatment effect over time in adult subjects with RRMS treated with ALKS 8700.;Primary end point(s): - Safety will be demonstrated by incidence of Adverse Events - All enrolled subjects who receive at least one dose of ALKS 8700 will be used in the safety and tolerability analysis;Timepoint(s) of evaluation of this end point: various study visits	—

Measure

Time frame

Main Objective: 1) to evaluate the long-term safety and tolerability of ALKS 8700 for up to 96 weeks of treatment in adult subjects with relapsing remitting multiple sclerosis (RRMS);Secondary Objective: 2) to evaluate treatment effect over time in adult subjects with RRMS treated with ALKS 8700.;Primary end point(s): - Safety will be demonstrated by incidence of Adverse Events - All enrolled subjects who receive at least one dose of ALKS 8700 will be used in the safety and tolerability analysis;Timepoint(s) of evaluation of this end point: various study visits

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: various study visits	—

Countries

Belgium, Bulgaria, Canada, Germany, Poland, Russian Federation, Serbia, Spain, Ukraine, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026