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Not yet recruitingNCT06949956FILYRAUpdated May 2, 2025

Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

An observational study in Relapsing Remitting Multiple Sclerosis, sponsored by Elpen Pharmaceutical Co. Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Elpen Pharmaceutical Co. Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (ARR) over a period of 2 years.

Participants who are already taking fingolimod as part of their regular medical care for MS will answer questions about their medical history for the past 1 year and for their status for the next 2 years.

Read the detailed description

The efficacy of fingolimod will be assessed:

  • by calculating the difference in annualized relapse rate (ARR) between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment
  • by calculating the change in EDSS score between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment.
02

Conditions studied

  • Relapsing Remitting Multiple Sclerosis

Keywords

  • RRMS
  • ARR
  • EDSS
  • Fingolimod
03

In context

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's planned enrollment of 140 is above the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Elpen Pharmaceutical Co. Inc. is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Browse Elpen Pharmaceutical Co. Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will enroll patients with relapsing-remitting multiple sclerosis (RRMS) who are already receiving the active substance fingolimod.

Patients must have at least 12 months of follow-up data available prior to study entry, sufficient to calculate the annualized relapse rate.

No additional diagnostic or monitoring procedures will be required for patient participation in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients over 18 years of age.
  2. Consent and compliance of participants with the treatments and procedures of the study.
  3. Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
  4. Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).
  5. Patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate.

Exclusion criteria

Exclusion Criteria:

  1. Patients under 18 years of age.
  2. Patients with a to taking fingolimod according to the drug's Summary of product Characteristics (SmPC).
  3. Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
  4. Patients participating in another research protocol.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • Multiple Sclerosis patients

    Multiple Sclerosis patients already receiving fingolimod and who have available follow-up data for at least 12 months prior to study entry, sufficient to calculate the annualized relapse rate.

06

What researchers measure

Primary outcomes

  1. Annualized Relapse Rate, ARR

    The difference in the annualized relapse rate (ARR) between the twelve-month period prior to study entry and that which will occur during the study.

    Time frame: 2 years

Secondary outcomes

  1. Expanded Disability Status Scale, EDSS

    The change in Expanded Disability Status Scale (EDSS) score between the 12-month period before study entry and during the study. EDSS scale provides a score ranging from 0 to 10, where lower scores indicate less disability and higher scores indicate greater disability.

    Time frame: 2 years

  2. Progression Independent of Relapse Activity, PIRA

    Assessment of patients with Progression Independent of Relapse Activity (PIRA), through the roving EDSS method.

    Time frame: 2 years

  3. Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical and imaging data (if available).

    Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical data (SDMT, 9 Hole Peg-Test, Timed 25-Foot Walk tests) and imaging data (new/enlarging or enhancing lesions on Magnetic Resonance Imaging MRI, if available).

    Time frame: 2 years

  4. Quality of Life (QoL) of patients with multiple sclerosis.

    Evaluation of Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire scores at 0, 12 and 24 months of treatment. MusiQoL questionnaire have responses describing frequency/extent of an event on a five-point scale ranging from 'never/not at all' (option'1') to 'always/very much' (option '5').

    Time frame: 2 years

  5. Safety evaluation of the drug throughout the treatment period.

    Recording of adverse events (AE) during treatment.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28. PubMed 24871874 ↗
  • Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11. PubMed 33174475 ↗
  • Bakirtzis C, Grigoriadou E, Boziki MK, Kesidou E, Siafis S, Moysiadis T, Tsakona D, Thireos E, Nikolaidis I, Pourzitaki C, Kouvelas D, Papazisis G, Tsalikakis D, Grigoriadis N. The Administrative Prevalence of Multiple Sclerosis in Greece on the Basis of a Nationwide Prescription Database. Front Neurol. 2020 Sep 29;11:1012. doi: 10.3389/fneur.2020.01012. eCollection 2020. PubMed 33132996 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Dec 2027, 30 months later.

Of 26 industry-sponsored observational studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's planned 30 months is close to that.

Counting every sponsor, half of 67 studies reached it within 41 months; a quarter within 23 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2025
First posted
Apr 29, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
May 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06949956
Lead sponsor
Elpen Pharmaceutical Co. Inc.
Collaborators
AHEPA University Hospital
Responsible party
Sponsor
First posted
Apr 29, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 2, 2025

Study contacts

Alexandros Ginis, MD
Contact
a.ginis@elpen.gr
003021011865734
Polyanthi Papanastasiou, MSc
Contact
p.papanastasiou@elpen.gr
003021011865777
Nikolaos Grigoriadis, MD
principal investigator · AHEPA University Hospital of Thessaloniki, Greece

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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