NCT02428231

Brief Summary

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3 multiple-sclerosis

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_3 multiple-sclerosis

Geographic Reach
4 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

April 23, 2015

Results QC Date

December 12, 2016

Last Update Submit

March 27, 2017

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)

    The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.

    from Week 2 (Baseline) to Week 14

Secondary Outcomes (4)

  • Average Change From Baseline in GSRS Scores During DMF Treatment

    Week 2 (Baseline), Week 14

  • Time to First Worsening From Baseline in GSRS Score

    Week 2 (Baseline), Week 14

  • Time to Recovery to Baseline From Last Occurrence of Worst GSRS Score

    Week 2 (Baseline), Week 14

  • Average Change From Baseline in GSRS Scores to the End of Weeks 4, 6, 8, 10, 12, and 14

    Week 2 (Baseline), Weeks 4, 6, 8, 10, 12, 14

Study Arms (2)

Standard Treatment (One-Week Titration)

ACTIVE COMPARATOR

120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks

Drug: dimethyl fumarate

Slow Up-Titration (Six-Week Titration)

EXPERIMENTAL

120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF twice daily for 6 weeks

Drug: dimethyl fumarate

Interventions

dimethyl fumarateDRUG

Participants will be dosed twice daily for 12 weeks.

Also known as: DMF, Tecfidera, BG00012
Slow Up-Titration (Six-Week Titration)Standard Treatment (One-Week Titration)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MS consistent with locally labeled indication for DMF
  • No prior treatment with DMF
  • Female subjects of childbearing potential who are not surgically sterile and male subjects must practice effective contraception during their participation in the study
  • Have had a recent complete blood count (CBC), including lymphocyte count, that does not preclude participation in the study, in the judgement of the investigator

You may not qualify if:

  • Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with GI signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints
  • Have other major comorbid conditions that preclude participation in the study, as determined by the investigator
  • Participant is pregnant, breastfeeding, or planning a pregnancy during the study period
  • Are receiving concomitant disease-modifying therapies for MS including, but not limited to, natalizumab, interferon beta, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Gilbert, Arizona, United States

Location

Research Site

Phoenix, Arizona, United States

Location

Research Site

Long Beach, California, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Avon, Indiana, United States

Location

Research Site

Franklin, Indiana, United States

Location

Research Site

Overland Park, Kansas, United States

Location

Research Site

Lewiston, Maine, United States

Location

Research Site

Asheville, North Carolina, United States

Location

Research Site

Cary, North Carolina, United States

Location

Research Site

Charlotte, North Carolina, United States

Location

Research Site

Wilmington, North Carolina, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Dallas, Texas, United States

Location

Research Site

Wenatchee, Washington, United States

Location

Research Site

Leuven, Belgium

Location

Research Site

Wilrijk, Belgium

Location

Research Site

Prague, Czechia

Location

Research Site

Merano, Bolzano, Italy

Location

Research Site

Montichiari, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Limitations and Caveats

The Sponsor decided to terminate the study as a result of an evaluation of ongoing development programs.

Results Point of Contact

Title
Biogen Study Medical Director
Organization
Biogen
clinicaltrials@biogen.com

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

May 5, 2017

Results First Posted

May 5, 2017

Record last verified: 2017-03

Locations

CZ(1)US(15)BE(2)IT(2)