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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ALKS 8700

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, Relapsing Remitting Multiple Sclerosis, RRMS, dimethyl fumarate, DMF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALKS 8700

Arm Description

Oral capsules taken twice daily.

Outcomes

Primary Outcome Measures

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

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is any AE that start or worsen on or after the date of first dose of study treatment. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Vital sign measurements included heart rate (low: <=50 beats per minute [bpm] and decrease >=15 bpm; High: >=120 bpm and increase >=15 bpm), systolic blood pressure (BP) (low: <=90 millimeters of mercury [mmHg] and decrease >=20 mmHg; High: >=180 mmHg and increase >=20 mmHg) and diastolic BP (low: <=50 mmHg and decrease >=15 mmHg; High: >=105 mmHg and increase >=15 mmHg).

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

Potentially clinically significant QTcF values (>450 to <=480 millisecond [msec], >480 to <=500 msec) at any post-baseline visit during treatment period were reported.

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

The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

Laboratory assessments included hematology, biochemistry, and urinalysis. Abnormality criteria: >=3xupper limit of normal (ULN) in alanine aminotransferase, aspartate aminotransferase; In millimoles per liter (mmol/L) [bicarbonate<15/>31, chloride<=90, potassium<3/>5.5, sodium<130/>150]; In mg per decilitre(mg/dL) {total bilirubin>=2.0, calcium<8.2/>12, total cholesterol>300, creatinine>=2.0, glucose<50/>200, cholesterol: High density lipoprotein (HDL)<=30, low density lipoprotein (LDL)>=160, triglycerides>=120 [female(F)]/>=160 [male(M)], urate>9/>8(F), blood urea nitrogen>30}; >3xULN in creatine kinase, lactate dehydrogenase; Hematocrit <=32(F)/<=37(M) percentage(%),3 point decrease from baseline; Hemoglobin<=9.5(F)/<=11.5(M)g/dL; Lymphocytes<0.5x10^9/L; In 10^3/microliter(uL) [Eosinophils>1; Absolute neutrophils<1.5; Platelets<75.1/>=700; Leukocytes<=2.8/>=16]; Albumin/creatinine>200g/kilograms(kg); Beta-2 microglobulin >0.3milligrams/liter(mg/L); Glucose/protein at least 2+.

Secondary Outcome Measures

Full Information

NCT ID

NCT02634307

First Posted

December 16, 2015

Last Updated

July 18, 2022

Sponsor

Biogen

Collaborators

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02634307

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

December 10, 2015 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

November 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

Collaborators

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

MS, Relapsing Remitting Multiple Sclerosis, RRMS, dimethyl fumarate, DMF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1057 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALKS 8700

Arm Type

Experimental

Arm Description

Oral capsules taken twice daily.

Intervention Type

Drug

Intervention Name(s)

ALKS 8700

Intervention Description

Administered as specified in the treatment arm.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Description

Time Frame

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

Title

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

Description

Potentially clinically significant QTcF values (>450 to <=480 millisecond [msec], >480 to <=500 msec) at any post-baseline visit during treatment period were reported.

Time Frame

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

Title

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

Description

Time Frame

Up to 98 weeks

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Annualized Relapse Rate (ARR)

Description

Relapse was defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, accompanied by one or more of the following: New objective neurological findings upon examination by the treating neurologist that are functionally consistent with findings on the Expanded Disability Status Scale [EDSS] (performed within 7 days of onset of symptoms) with an increase over the prior visit of ≥ 0.5 for the total score, an increase of ≥ 2 in 1 functional system (FS), except bladder/cognitive changes, and/or, an increase of ≥ 1 in 2 FS, except bladder/cognitive changes. The relapse rate for an individual participant was calculated as the number of relapses for that participant divided by the number of participant-years followed. The ARR for each enrollment group was calculated as the total number of relapses experienced in the group divided by the total number of participant-years on study.

Time Frame

Up to 96 weeks

Title

Percentage of Participants With Multiple Sclerosis (MS) Relapse

Description

Time Frame

Up to 96 weeks

Title

Change From Baseline in Expanded Disability Status Scale (EDSS) Score

Description

The EDSS is used to measure and evaluate MS participants' 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. Higher scores indicate more disability. Positive change from baseline indicates more disability.

Time Frame

Baseline up to Week 96

Title

Change From Baseline in Timed 25-Foot Walk Test (T25-FW) Score

Description

The T25-FW is a reliable quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant was directed to one end of a clearly marked 25-foot course and was instructed to walk 25 feet as quickly as possible, but safely. Participants were allowed to use assistive devices (canes, crutches, walkers) as needed. The time was calculated from when the lead foot crosses the start point to when the participant had reached the 25-foot mark. The task was immediately administered again by having the participant walk back the same distance. The score for the T25-FW was calculated as the average of the 2 completed trials. A negative change from Baseline indicates improvement.

Time Frame

Baseline up to Week 96

Title

Change From Baseline in the EuroQol 5-Dimension 5-Level Visual Analog Scale (EQ-5D-5L VAS) Score

Description

The EQ-5D-5L is an instrument designed to assess decrements in health. The EQ-5D-5L includes a 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). The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). Higher scores indicate good health. Positive change from baseline indicates improved health.

Time Frame

Baseline up to Week 96

Title

Change From Baseline in the EQ-5D-5L Index Score

Description

The EQ-5D-5L is an instrument designed to assess decrements in health. The EQ-5D-5L includes a 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). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher scores indicate good health. Positive change from baseline indicates improved health.

Time Frame

Baseline up to Week 96

Title

Change From Baseline in the 12-item Short Form Health Survey (SF-12) Score

Description

The SF-12 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. Positive change from baseline indicates improved health.

Time Frame

Baseline up to Week 96

Title

Time to Onset of 12-week Confirmed Disability Progression

Description

The time to onset of 12-week confirmed disability progression is defined as the time from baseline to the first disability progression that is confirmed at the next regularly scheduled visit ≥ 12 weeks after the initial disability progression. Disability progression is defined by one of the following: an EDSS increase of at least 1.5 points from baseline EDSS = 0, an EDSS increase of at least a 1.0 point from baseline EDSS between 1.0 and 5.5 (inclusive), or an EDSS increase of at least 0.5 points from baseline EDSS = 6.0.

Time Frame

Up to Week 96

Title

Percentage of Participants With No Evidence of Disease Activity (NEDA) at Week 96

Description

The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. The definition of NEDA-4 was the above definition of NEDA-3 with the addition of a mean annualized rate of brain volume loss of less than 0.4% where annualized rate of brain volume loss was derived from percentage brain volume change (PBVC) from baseline and was calculated as ([PBVC/100+1]^[365.25/days]-1) × 100.

Time Frame

Week 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Alkermes Investigational Site

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Alkermes Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Alkermes Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Alkermes Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Alkermes Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Alkermes Investigational Site

City

Berkeley

State/Province

California

ZIP/Postal Code

94705

Country

United States

Facility Name

Alkermes Investigational Site

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Alkermes Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Alkermes Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Alkermes Investigational Site

City

Basalt

State/Province

Colorado

ZIP/Postal Code

81621

Country

United States

Facility Name

Alkermes Investigational Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80111

Country

United States

Facility Name

Alkermes Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Alkermes Investigational Site

City

Middlebury

State/Province

Connecticut

ZIP/Postal Code

06762

Country

United States

Facility Name

Alkermes Investigational Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Alkermes Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Alkermes Investigational Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Alkermes Investigational Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Alkermes Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Alkermes Investigational Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Alkermes Investigational Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Alkermes Investigational Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Alkermes Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Alkermes Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Alkermes Investigational Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Alkermes Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312-4201

Country

United States

Facility Name

Alkermes Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

Alkermes Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Alkermes Investigational Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Alkermes Investigational Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Alkermes Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Alkermes Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Alkermes Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Alkermes Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66213

Country

United States

Facility Name

Alkermes Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

Country

United States

Facility Name

Alkermes Investigational Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

Alkermes Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70810

Country

United States

Facility Name

Alkermes Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Alkermes Investigational Site

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

Alkermes Investigational Site

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Alkermes Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Alkermes Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Alkermes Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

Alkermes Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Alkermes Investigational Site

City

Patchogue

State/Province

New York

ZIP/Postal Code

11772

Country

United States

Facility Name

Alkermes Investigational Site

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Alkermes Investigational Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Alkermes Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Alkermes Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Alkermes Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Alkermes Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Alkermes Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Alkermes Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Alkermes Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Alkermes Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Alkermes Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Alkermes Investigational Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Alkermes Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Alkermes Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Alkermes Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Alkermes Investigational Site

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Alkermes Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29307

Country

United States

Facility Name

Alkermes Investigational Site

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Alkermes Investigational Site

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

Alkermes Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

Alkermes Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Alkermes Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Alkermes Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Alkermes Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Alkermes Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

Alkermes Investigational Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

Alkermes Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23228

Country

United States

Facility Name

Alkermes Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Alkermes Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Alkermes Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Alkermes Investigational Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Alkermes Investigational Site

City

Fraiture

ZIP/Postal Code

4557

Country

Belgium

Facility Name

Alkermes Investigational Site

City

La Louviere

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Alkermes Investigational Site

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

Alkermes Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Alkermes Investigational Site

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Alkermes Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Alkermes Investigational Site

City

Sofia

ZIP/Postal Code

1797

Country

Bulgaria

Facility Name

Alkermes Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 1W2

Country

Canada

Facility Name

Alkermes Investigational Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Alkermes Investigational Site

City

Berlin

ZIP/Postal Code

12099

Country

Germany

Facility Name

Alkermes Investigational Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Alkermes Investigational Site

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Facility Name

Alkermes Investigational Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Alkermes Investigational Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Alkermes Investigational Site

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

Alkermes Investigational Site

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Alkermes Investigational Site

City

Katowice

ZIP/Postal Code

40-123

Country

Poland

Facility Name

Alkermes Investigational Site

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Alkermes Investigational Site

City

Kielce

ZIP/Postal Code

25-726

Country

Poland

Facility Name

Alkermes Investigational Site

City

Krakow

ZIP/Postal Code

31-505

Country

Poland

Facility Name

Alkermes Investigational Site

City

Lodz

ZIP/Postal Code

90-324

Country

Poland

Facility Name

Alkermes Investigational Site

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

Alkermes Investigational Site

City

Plewiska

ZIP/Postal Code

62-064

Country

Poland

Facility Name

Alkermes Investigational Site

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Alkermes Investigational Site

City

Krasnoyarsk

ZIP/Postal Code

66037

Country

Russian Federation

Facility Name

Alkermes Investigational Site

City

Nizhniy Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Alkermes Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Alkermes Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Alkermes Investigational Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Alkermes Investigational Site

City

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Alkermes Investigational Site

City

Madrid

ZIP/Postal Code

28905

Country

Spain

Facility Name

Alkermes Investigational Site

City

Santa Cruz de Tenerife

ZIP/Postal Code

38010

Country

Spain

Facility Name

Alkermes Investigational Site

City

Dnipro

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Kharkiv

ZIP/Postal Code

61103

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Lviv

ZIP/Postal Code

79000

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Zaporizhzhya

ZIP/Postal Code

69035

Country

Ukraine

Facility Name

Alkermes Investigational Site

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

35211872

Citation

Wray S, Then Bergh F, Wundes A, Arnold DL, Drulovic J, Jasinska E, Bowen JD, Negroski D, Naismith RT, Hunter SF, Gudesblatt M, Chen H, Lyons J, Shankar SL, Kapadia S, Mendoza JP, Singer BA. Efficacy and Safety Outcomes with Diroximel Fumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study. Adv Ther. 2022 Apr;39(4):1810-1831. doi: 10.1007/s12325-022-02068-7. Epub 2022 Feb 24.

Results Reference

derived

PubMed Identifier

31680631

Citation

Naismith RT, Wolinsky JS, Wundes A, LaGanke C, Arnold DL, Obradovic D, Freedman MS, Gudesblatt M, Ziemssen T, Kandinov B, Bidollari I, Lopez-Bresnahan M, Nangia N, Rezendes D, Yang L, Chen H, Liu S, Hanna J, Miller C, Leigh-Pemberton R. Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study. Mult Scler. 2020 Nov;26(13):1729-1739. doi: 10.1177/1352458519881761. Epub 2019 Nov 4.

Results Reference

derived

PubMed Identifier

31538304

Citation

Palte MJ, Wehr A, Tawa M, Perkin K, Leigh-Pemberton R, Hanna J, Miller C, Penner N. Improving the Gastrointestinal Tolerability of Fumaric Acid Esters: Early Findings on Gastrointestinal Events with Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis from the Phase 3, Open-Label EVOLVE-MS-1 Study. Adv Ther. 2019 Nov;36(11):3154-3165. doi: 10.1007/s12325-019-01085-3. Epub 2019 Sep 19.

Results Reference

derived

Learn more about this trial

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

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

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial