Relapsing Remitting Multiple SclerosisPhase 3NCT03093324

A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

A Phase 3 study testing ALKS 8700 and Dimethyl Fumarate in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 67 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Relapsing Remitting Multiple Sclerosis
What is being tested?: ALKS 8700 and Dimethyl Fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 506 participants
Where: 67 sitesin 3 countries
Study dates: 15 Mar 2017to 27 Jun 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Capable of understanding and complying with the protocol
Has a confirmed diagnosis of RRMS
Neurologically stable with no evidence of relapse within 30 days prior to randomization
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal

Who cannot join

Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening

Show all 12Show fewer

History of a myocardial infarction, including a silent myocardial infarction or unstable angina
History of clinically significant drug or alcohol abuse within the past year prior to screening
Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
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
Prior use of Dimethyl Fumarate (DMF)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

67 sites in 3 countries.

Country

City, postcode or hospital

67 sites in 3 countries

United States57 sites

Alkermes Investigational Site
Albuquerque, New Mexico, 87106
Alkermes Investigational Site
Alexandria, Louisiana, 71301
Alkermes Investigational Site
Atlanta, Georgia, 30312
Alkermes Investigational Site
Atlanta, Georgia, 30327
Alkermes Investigational Site
Atlanta, Georgia, 30342
Alkermes Investigational Site
Atlantis, Florida, 33462
Alkermes Investigational Site
Basalt, Colorado, 81621
Alkermes Investigational Site
Bradenton, Florida, 34209
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Centennial, Colorado, 80112
Alkermes Investigational Site
Charleston, South Carolina, 29406
Alkermes Investigational Site
Charlotte, North Carolina, 28203
Alkermes Investigational Site
Columbus, Georgia, 31904
Alkermes Investigational Site
Columbus, Ohio, 43221
Alkermes Investigational Site
Cullman, Alabama, 35058
Alkermes Investigational Site
Dallas, Texas, 75231
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Denver, Colorado, 80209
Alkermes Investigational Site
Des Moines, Iowa, 50314
Alkermes Investigational Site
Detroit, Michigan, 48202
Alkermes Investigational Site
Evanston, Illinois, 60201
Alkermes Investigational Site
Franklin, Tennessee, 37064
Alkermes Investigational Site
Golden Valley, Minnesota, 55422
Alkermes Investigational Site
Greensboro, North Carolina, 27405
Alkermes Investigational Site
Greer, South Carolina, 29650
Alkermes Investigational Site
Houston, Texas, 77030
Alkermes Investigational Site
Houston, Texas, 77074
Alkermes Investigational Site
Knoxville, Tennessee, 37922
Alkermes Investigational Site
Lenexa, Kansas, 66214
Alkermes Investigational Site
Long Beach, California, 90806
Alkermes Investigational Site
Maitland, Florida, 32751
Alkermes Investigational Site
Middlebury, Connecticut, 06762
Alkermes Investigational Site
Naples, Florida, 34105
Alkermes Investigational Site
Newport News, Virginia, 23601
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73104
Alkermes Investigational Site
Old Point Station, South Carolina, 29707
Alkermes Investigational Site
Ormond Beach, Florida, 32174
Alkermes Investigational Site
Patchogue, New York, 11772
Alkermes Investigational Site
Phoenix, Arizona, 85004
Alkermes Investigational Site
Richmond, Virginia, 23226
Alkermes Investigational Site
San Diego, California, 92103
Alkermes Investigational Site
Sarasota, Florida, 34233
Alkermes Investigational Site
Seattle, Washington, 98101
Alkermes Investigational Site
Seattle, Washington, 98122
Alkermes Investigational Site
Seattle, Washington, 98133
Alkermes Investigational Site
Spartanburg, South Carolina, 29307
Alkermes Investigational Site
St Louis, Missouri, 63104
Alkermes Investigational Site
St Louis, Missouri, 63110
Alkermes Investigational Site
St Louis, Missouri, 63131
Alkermes Investigational Site
Stamford, Connecticut, 06905
Alkermes Investigational Site
Stony Brook, New York, 11794
Alkermes Investigational Site
Syracuse, New York, 13210
Alkermes Investigational Site
Tampa, Florida, 33634
Alkermes Investigational Site
Tucson, Arizona, 85704
Alkermes Investigational Site
Vero Beach, Florida, 32960
Alkermes Investigational Site
Washington D.C., District of Columbia, 20007
Alkermes Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Poland6 sites

Alkermes Investigational Site
Gdansk, 80-803
Alkermes Investigational Site
Katowice, 40-123
Alkermes Investigational Site
Kielce, 25-726
Alkermes Investigational Site
Lodz, 90-324
Alkermes Investigational Site
Plewiska, 62-064
Alkermes Investigational Site
Szczecin, 70-111

Other trials in Poland

Germany4 sites

Alkermes Investigational Site
Dresden
Alkermes Investigational Site
Leipzig
Alkermes Investigational Site
Ulm
Alkermes Investigational Site
Westerstede

Other trials in Germany

About this study

Official title: A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate

The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.

Conditions: Relapsing Remitting Multiple Sclerosis
Being tested: ALKS 8700, Dimethyl Fumarate
Keywords: RRMS, Multiple Sclerosis, MS, Alkermes, ALKS 8700, Dimethyl Fumarate, DMF, Tecfidera
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALKS 8700Drug
Administered as specified in the treatment arm.
Dimethyl FumarateDrug
Also called Tecfidera
Administered as specified in the treatment arm.

Study groups in NCT03093324
Study group	Role	What they receive
ALKS 8700	Experimental	Oral capsules, administered orally twice daily. Receives: Drug: ALKS 8700
Dimethyl Fumarate	Active comparator	Oral capsules, administered orally twice daily. Receives: Drug: Dimethyl Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for both Parts A and B

Secondary outcomes (8)

Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for Part B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for both Parts A and B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for both Parts A and B
Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for both Parts A and B
Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for both Parts A and B
Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Measured: End of treatment (up to Week 6) for both Parts A and B
Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. Scores were averaged for 5-week treatment period.
Measured: End of treatment (up to Week 6) for both Parts A and B
Number of Participants With Adverse Events (AEs)
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 laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: End of study (up to Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201727 Jun 2019

First posted28 Mar 2017
Study start15 Mar 2017
Primary completion27 Jun 2019
Study completion27 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03093324
Sponsor's protocol ID: ALK8700-A302
Other IDs: 2017-001294-16, 2017
Status last verified: Jul 2020
First submitted: 16 Mar 2017
Last updated: 14 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38878121
Wundes A, Wray S, Gold R, Singer BA, Jasinska E, Ziemssen T, de Seze J, Repovic P, Chen H, Hanna J, Messer J, Miller C, Naismith RT. Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study. Ther Adv Neurol Disord. 2021 Mar 19;14:1756286421993999. doi: 10.1177/1756286421993999. eCollection 2021.
PubMed 33796143
Naismith RT, Wundes A, Ziemssen T, Jasinska E, Freedman MS, Lembo AJ, Selmaj K, Bidollari I, Chen H, Hanna J, Leigh-Pemberton R, Lopez-Bresnahan M, Lyons J, Miller C, Rezendes D, Wolinsky JS; EVOLVE-MS-2 Study Group. Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. CNS Drugs. 2020 Feb;34(2):185-196. doi: 10.1007/s40263-020-00700-0.
PubMed 31953790

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
ClinicalTrials.gov ID: NCT03093324
Acronym / sponsor ID: ALK8700-A302
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: RRMS, Multiple Sclerosis, MS, Alkermes, ALKS 8700, Dimethyl Fumarate, DMF, Tecfidera
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 506 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: 15 Mar 2017 (actual)
Primary completion: 27 Jun 2019 (actual)
Study completion: 27 Jun 2019 (actual)
First posted: 28 Mar 2017 (actual)
Results: Posted 14 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ALKS 8700	Experimental	Drug: ALKS 8700Oral capsules, administered orally twice daily.
Dimethyl Fumarate	Active comparator	Drug: Dimethyl FumarateOral capsules, administered orally twice daily.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Capable of understanding and complying with the protocol
Has a confirmed diagnosis of RRMS
Neurologically stable with no evidence of relapse within 30 days prior to randomization
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal

Key exclusion criteria (12 listed)

Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALKS 8700Administered as specified in the treatment arm.	Drug	ALKS 8700
Dimethyl FumarateAlso: TecfideraAdministered as specified in the treatment arm.	Drug	Dimethyl Fumarate

Primary outcome

Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.

8 secondary outcomes

Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
Time frame: End of treatment (up to Week 6) for Part B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B
Time frame: End of treatment (up to Week 6) for both Parts A and B
Number of Participants With Adverse Events (AEs)
Time frame: End of study (up to Week 10)

Results and safety

Results posted to the registry on 14 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALKS 8700	254	245
Dimethyl Fumarate (DMF)	252	233

Primary outcome: Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B

Time frame: End of treatment (up to Week 6) for both Parts A and B. Mean (Standard Deviation). Unit: days

Measure	ALKS 8700 n = 253	Dimethyl Fumarate (DMF) n = 249
Value	1.5 (2.85)	2.5 (4.68)

ALKS 8700 vs Dimethyl Fumarate (DMF): Rate ratio: 0.542 (95% CI 0.390 to 0.754), p = 0.0003, Negative Binomial Regression Model

Population analysed: The full analysis set (FAS) population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: End of study (up to Week 10). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALKS 8700	4 of 253 (1.6%)	175 of 253 (69.2%)	0 of 253
Dimethyl Fumarate (DMF)	3 of 251 (1.2%)	191 of 251 (76.1%)	0 of 251

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38878121Bowen 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.
Derived from this study: PubMed 33796143Wundes A, Wray S, Gold R, Singer BA, Jasinska E, Ziemssen T, de Seze J, Repovic P, Chen H, Hanna J, Messer J, Miller C, Naismith RT. Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study. Ther Adv Neurol Disord. 2021 Mar 19;14:1756286421993999. doi: 10.1177/1756286421993999. eCollection 2021.
Derived from this study: PubMed 31953790Naismith RT, Wundes A, Ziemssen T, Jasinska E, Freedman MS, Lembo AJ, Selmaj K, Bidollari I, Chen H, Hanna J, Leigh-Pemberton R, Lopez-Bresnahan M, Lyons J, Miller C, Rezendes D, Wolinsky JS; EVOLVE-MS-2 Study Group. Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. CNS Drugs. 2020 Feb;34(2):185-196. doi: 10.1007/s40263-020-00700-0.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

67 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALKS 8700 and Dimethyl Fumarate in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 67 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B (time frame: End of treatment (up to Week 6) for both Parts A and B). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03093324, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.