Trial · NCT03345940

Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis

NCT03345940, Phase 4, Terminated, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis. Trials, record NCT03345940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03345940

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
NCT number: NCT03345940
Status: Terminated
Phases: Phase 4
Enrollment: 55 participants, actual
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions: Relapsing Remitting Multiple Sclerosis
Interventions: Fingolimod, Dimethyl Fumarate
First posted: 2017-11-17
Last updated: 2019-10-31

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	effectiveness of fingolimod 0.5 mg once daily versus dimethyl-fumarate 240 mg twice daily	24 Months	losing the NEDA status
Secondary	Annual relapse rate	over 12 and 24 months	compare the effectiveness of the two oral DMTs in terms of prevention of clinical relapses
Secondary	Number of Gd+ MRI lesions	at 12 and 24 months	compare the effectiveness of the two oral DMTs in terms of prevention of MRI activity
Secondary	Brain volume loss	at 12 and 24 months	compare the effectiveness of the two oral DMTs in terms of prevention of brain atrophy
Secondary	Prevention of sustained disability progression (EDSS worsening)	over 24 months	percentage of patients with confirmed increase of 1 point on the EDSS scale
Secondary	Prevention of Objective sustained disability progression	over 12 and 24 months	percentage of patients with change in gait performance (limb range of motion) assessed by inertial sensors
Secondary	Patient-NEDA	over 24 months	Percentage of patients maintaining patient-NEDA status
Secondary	Prevention of Cognitive decline	over 12 and 24 months	Change in cognitive impairment index (CII) assessed by Brief Repeatable Battery of Neuropsychological tests (BRB-N)
Secondary	Evaluation of social cognition	over 12 and 24 months	Change in social cognition assessed by Story based Empathy task (SET)
Secondary	Evaluation of quality of decision making	over 12 and 24 months	Change in quality of decision making assessed by Game of Dice Task (GDT)

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20089952	BACKGROUND	PubMed
20089954	BACKGROUND	PubMed
21397565	BACKGROUND	PubMed
21842619	BACKGROUND	PubMed
22992072	BACKGROUND	PubMed
22992073	BACKGROUND	PubMed
24195574	BACKGROUND	PubMed
24685276	BACKGROUND	PubMed
25414048	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Game of Dice Task	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03345940

GET https://conductscience.org/api/trials/v1/NCT03345940/registered

API reference For AI assistants