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

• Register: EUCTR
• Last refreshed on: 28 March 2022
• Main ID: EUCTR2015-005160-41-PL
• Date of registration: 13/04/2016
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis
• Scientific 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 - EVOLVE-MS-1
• Date of first enrolment: 07/06/2016
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005160-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: N/A
• Affiliation: Biogen Idec Research Ltd

• Name: N/A
• Affiliation: Biogen Idec Research Ltd

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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 8700
Other descriptive name: ALKS 8700
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 231-

Primary Outcome(s)

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

Secondary Objective: 2) to evaluate treatment effect over time in adult subjects with RRMS treated with ALKS 8700.

Timepoint(s) of evaluation of this end point: various study visits

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 Outcome(s)

Timepoint(s) of evaluation of this end point: various study visits

Secondary end point(s): N/A

Secondary ID(s)

2015-005160-41-DE

NCT02634307

ALK8700-A301

Source(s) of Monetary Support

Biogen Idec Research Ltd

Ethics review

Status: Approved
Approval date: 19/04/2016
Contact: