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

Phase 1

• Conditions: Relapsing Remitting Multiple Sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2015-005160-41-BG
• Lead Sponsor: Alkermes, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-04
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- All enrolled subjects who receive at least one dose of ALKS 8700 will be used in the safety and tolerability analysis<br>;Timepoint(s) of evaluation of this end point: various study visits

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: various study visits