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

NCT ID: NCT02634307

Last Updated: 2022-07-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1057 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-10

Study Completion Date

2021-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALKS 8700

Oral capsules taken twice daily.

Group Type EXPERIMENTAL

ALKS 8700

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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ALKS 8700

Administered as specified in the treatment arm.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Alkermes Investigational Site

Cullman, Alabama, United States

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Alkermes Investigational Site

Phoenix, Arizona, United States

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Alkermes Investigational Site

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Berkeley, California, United States

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Loma Linda, California, United States

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Long Beach, California, United States

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San Diego, California, United States

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Basalt, Colorado, United States

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Centennial, Colorado, United States

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Denver, Colorado, United States

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Middlebury, Connecticut, United States

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Stamford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Bradenton, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Naples, Florida, United States

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Ormond Beach, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Evanston, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Alexandria, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Detroit, Michigan, United States

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Traverse City, Michigan, United States

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Golden Valley, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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Patchogue, New York, United States

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Plainview, New York, United States

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Stony Brook, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Cordova, Tennessee, United States

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Franklin, Tennessee, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Salt Lake City, Utah, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Bruges, , Belgium

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Fraiture, , Belgium

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La Louvière, , Belgium

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Blagoevgrad, , Bulgaria

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Gatineau, Quebec, Canada

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Berlin, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Leipzig, , Germany

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Ulm, , Germany

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Ulm, , Germany

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Westerstede, , Germany

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Gdansk, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Plewiska, , Poland

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Szczecin, , Poland

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Krasnoyarsk, , Russia

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Nizhny Novgorod, , Russia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Barcelona, , Spain

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Madrid, , Spain

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Santa Cruz de Tenerife, , Spain

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Zaporizhzhya, , Ukraine

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Zaporizhzhya, , Ukraine

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Countries

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United States Belgium Bulgaria Canada Germany Poland Russia Serbia Spain Ukraine

References

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Singer BA, Wray S, Gudesblatt M, Bumstead B, Ziemssen T, Bonnell A, Scaramozza M, Levin S, Shanmugasundaram M, Chen H, Mendoza JP, Lewin JB, Shankar SL. Lymphopenia is Not the Primary Therapeutic Mechanism of Diroximel Fumarate in Relapsing-Remitting Multiple Sclerosis: Subgroup Analyses of the EVOLVE-MS-1 Study. Neurol Ther. 2024 Aug;13(4):1273-1285. doi: 10.1007/s40120-024-00637-2. Epub 2024 Jun 27.

Reference Type DERIVED
PMID: 38935202 (View on PubMed)

Bowen JD, Stulc J, Hunter SF, Chen H, Lewin JB, Scaramozza M, Bozin I, Then Bergh F. Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study. Adv Ther. 2024 Aug;41(8):3396-3406. doi: 10.1007/s12325-024-02901-1. Epub 2024 Jun 15.

Reference Type DERIVED
PMID: 38878121 (View on PubMed)

Jiang T, Ziemssen T, Wray S, Shen C, Soderbarg K, Lewin JB, Bozin I, Freedman MS. Matching-Adjusted Indirect Comparisons of Diroximel Fumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis. CNS Drugs. 2023 May;37(5):441-452. doi: 10.1007/s40263-023-01002-x. Epub 2023 May 8.

Reference Type DERIVED
PMID: 37155132 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35211872 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31680631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31538304 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-005160-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALK8700-A301

Identifier Type: -

Identifier Source: org_study_id

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